Protocol summary
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Study aim
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Comparison of the prophylactic effects of intravenous injection of dexmedetomidine, Ondansetron, and pethidine on postoperative shivering.
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Design
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A randomized, controlled, double-blind, placebo-controlled clinical trial with a sample size of 128 patients was designed in a phase 3 trial.
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Settings and conduct
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This study is a double-blind randomized clinical trial that will be performed in the Alzahra hospital.the target population is patients undergoing abdominal surgery with general anesthesia.128 patients well be selected having inclusion criteria and distributed by random allocation method in one of 4 groups.
In each group, one of the dexmedetomidine, ondansetron, pethidine and distilled water too (as a placebo) is injected and at the end of the operation the patient is evaluated for postoperative shivering.
. The method of blinding is that patients are unaware of the type of drug they are given and also drugs will be provided in similar syringes and coded for those by a non-study operating room staff and given to the study expert to inject.
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Participants/Inclusion and exclusion criteria
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Patients who are the candidates for abdominal surgery under general anesthesia are included in this study if they have no underlying problem.
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Intervention groups
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In Group D: 0.5 μg /kg Dexmedetomidine
in group O: 0.1 mg/kg Ondansetron
in group P: 0.5 mg/kg Pethidine
in group N: distilled water
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Main outcome variables
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shivering
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160307026950N18
Registration date:
2020-04-01, 1399/01/13
Registration timing:
prospective
Last update:
2022-07-12, 1401/04/21
Update count:
1
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Registration date
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2020-04-01, 1399/01/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-09-22, 1399/07/01
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Expected recruitment end date
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2020-12-21, 1399/10/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the prophylactic effects of intravenous injection of Dexmedetomidine, Ondansetron, and pethidine on postoperative shivering of abdominal surgery under general anesthesia
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Public title
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The investigation of effects of dexmedetomedine, ondansetron and pethidin on postoperative shivering
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
ASA class I and II
Candidate for abdominal surgery under general anesthesia
The range from 18-60 years of age
The patient's consent to participate in the study
Exclusion criteria:
A History of TCA, MAOI, vasoactive agent, painkiller and opiate medication
Musculoskeletal and nervous system diseases, thyroid diseases
Dysautonomia, fever, pregnancy, obesity(BMI>27)
The history of cardiovascular, respiratory, enocrin or neurologic diseases
Allergic to sulfate of magnesium, ketamine and pethidin
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
128
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Sampling will be done by the simple method and patients depending on the time of entry who meet the necessary conditions entered into the study in order to reach the sample size. Also, patients will be distributed in a randomized block allocation method and with the required number among the groups.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The method of blinding is that patients are unaware of the type of drug they are given and also drugs and placebo provided in similar syringes and coded for those by the researcher and given to the study expert to inject. and the hemodynamic changes are monitored and recorded, so the attending and the clinical caregiver and the examiner and data analyzer will not understand the type of medication and the investigator deciphers the codes after data analysis.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-06-30, 1398/04/09
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Ethics committee reference number
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IR.MUI.MED.REC.1398.182
Health conditions studied
1
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Description of health condition studied
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postoperative shivering
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Shivering
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Timepoint
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On arrival to the recovery room and then every 15 minutes for one hour.
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Method of measurement
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Shivering severity is assessed by Crassly and Mahajan Score
2
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Description
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Central temperature
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Timepoint
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Before surgery, before drug administration, after intubation, every 15 minutes during the anesthesia, at the end of anesthesia, after extubation, on arrival to the recovery room and then every 15 minutes for one hour
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Method of measurement
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Tympanic thermometer
3
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Description
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Peripheral temperature
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Timepoint
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Before surgery, before drug administration, after intubation, every 15 minutes during the anesthesia, at the end of anesthesia, after extubation, on arrival to the recovery room and then every 15 minutes for one hour
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Method of measurement
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Thermometer
4
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Description
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The level of sedation
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Timepoint
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At the base time; after the procedure and then every 15 minutes until discharge of recovery.
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Method of measurement
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Using the Ramsay Sedation Scale
5
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Description
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Severity of Pain
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Timepoint
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At the base time; after the procedure and then every 15 minutes until discharge of recovery.
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Method of measurement
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Using the Visual Analogue Scale
6
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Description
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Systolic blood pressure
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Timepoint
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Before surgery, every 15 minutes during the anesthesia, on arrival to the recovery room and then every 15 minutes
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Method of measurement
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Non invasive manometer
7
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Description
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Diastolic blood pressure
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Timepoint
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Before surgery, every 15 minutes during the anesthesia, on arrival to the recovery room and then every 15 minutes
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Method of measurement
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Non invasive manometer
8
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Description
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Oxygen saturation
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Timepoint
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since entering the operating room until leaving the recovery room
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Method of measurement
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Pulse oximeter
9
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Description
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Heart rate
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Timepoint
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since entering the operating room until leaving the recovery room
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Method of measurement
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Heart monitoring device
10
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Description
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Mean Arterial Blood Pressure
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Timepoint
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Before surgery, every 15 minutes during the anesthesia, on arrival to the recovery room and then every 15 minutes
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Method of measurement
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Non invasive blood pressure measurement
11
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Description
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Recovery length
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Timepoint
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On arrival to the recovery room and then every 15 minutes till recovery room
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Method of measurement
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Watch or clock
Secondary outcomes
1
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Description
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Nausea
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Timepoint
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Recovery length
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Method of measurement
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Questioning
2
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Description
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Vomiting
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Timepoint
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Recovery length
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Method of measurement
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Observing
3
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Description
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Itching
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Timepoint
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Recovery length
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Method of measurement
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Questioning
4
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Description
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Atropine taken dose
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Timepoint
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Since the beginning of the operation until the end of the recovery length
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Method of measurement
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Asking from the anesthesia technician
5
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Description
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Pethidine taken dose
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Timepoint
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Since the beginning of the operation until the end of the recovery length
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Method of measurement
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Asking from the anesthesia technician
6
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Description
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Ephedrine taken dose
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Timepoint
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Since the beginning of the operation until the end of the recovery length
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Method of measurement
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Asking from the anesthesia technician
Intervention groups
1
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Description
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Intervention group D: First the written consent will be obtained from patients. after placing the patients on the bed, standard monitoring will be applied (including a pulse oximeter, capnograph, Manometer,ECG and basic vital signs ). for Group D: 0.5 μg /kg intravenous Dexmedetomidine will be injected after discontinuation the anesthetic drug, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times.
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Category
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Prevention
2
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Description
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Intervention group P: First the written consent will be obtained from patients. after placing the patients on the bed, standard monitoring devices will be applied (including a pulse oximeter, capnograph, Manometer,ECG and basic vital signs ). for group P: 0.5 mg/kg Pethidine will be injected after discontinuing the anesthetic drug, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times.
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Category
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Prevention
3
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Description
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Intervention group O: First the written consent will beobtained from patients. after placing the patients on the bed, standard monitoring devices will be applied (including a pulse oximeter, capnograph, Manometer,ECG and basic vital signs ). for group O; 0.1 mg/kg Ondansetron will be injected after discontinuing the anesthetic drug, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times.
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Category
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Prevention
4
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Description
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Control group N; First the written consent will be obtained from patients. after placing the patients on the bed, standard monitoring devices will be applied (including a pulse oximeter, capnograph, Manometer,ECG and basic vital signs ). for group N, distilled wate will be injected after discontinuing the anesthetic drug, and mean arterial blood pressure, heart rate, systolic and diastolic blood pressure, and other variables are considered at the desired times.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Isfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available