Comparison of the prophylactic effects of intravenous injection of Dexmedetomidine, Ondansetron, and pethidine on postoperative shivering of abdominal surgery under general anesthesia
Comparison of the prophylactic effects of intravenous injection of dexmedetomidine, Ondansetron, and pethidine on postoperative shivering.
Design
A randomized, controlled, double-blind, placebo-controlled clinical trial with a sample size of 128 patients was designed in a phase 3 trial.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Patients who are the candidates for abdominal surgery under general anesthesia are included in this study if they have no underlying problem.
Intervention groups
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
Main outcome variables
shivering
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N18
Registration date:2020-04-01, 1399/01/13
Registration timing:prospective
Last update:2020-04-01, 1399/01/13
Update count:1
Registration date
2020-04-01, 1399/01/13
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the prophylactic effects of intravenous injection of Dexmedetomidine, Ondansetron, and pethidine on postoperative shivering of abdominal surgery under general anesthesia
Public title
The investigation of effects of dexmedetomedine, ondansetron and pethidin on postoperative shivering
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan Province, Isfahan, Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶-۷۳۴۶۱
Approval date
2019-06-30, 1398/04/09
Ethics committee reference number
IR.MUI.MED.REC.1398.182
Health conditions studied
1
Description of health condition studied
postoperative shivering
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Shivering
Timepoint
On arrival to the recovery room and then every 15 minutes for one hour.
Method of measurement
Shivering severity is assessed by Crassly and Mahajan Score
2
Description
Central temperature
Timepoint
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
Method of measurement
Tympanic thermometer
3
Description
Peripheral temperature
Timepoint
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
Method of measurement
Thermometer
4
Description
The level of sedation
Timepoint
At the base time; after the procedure and then every 15 minutes until discharge of recovery.
Method of measurement
Using the Ramsay Sedation Scale
5
Description
Severity of Pain
Timepoint
At the base time; after the procedure and then every 15 minutes until discharge of recovery.
Method of measurement
Using the Visual Analogue Scale
6
Description
Systolic blood pressure
Timepoint
Before surgery, every 15 minutes during the anesthesia, on arrival to the recovery room and then every 15 minutes
Method of measurement
Non invasive manometer
7
Description
Diastolic blood pressure
Timepoint
Before surgery, every 15 minutes during the anesthesia, on arrival to the recovery room and then every 15 minutes
Method of measurement
Non invasive manometer
8
Description
Oxygen saturation
Timepoint
since entering the operating room until leaving the recovery room
Method of measurement
Pulse oximeter
9
Description
Heart rate
Timepoint
since entering the operating room until leaving the recovery room
Method of measurement
Heart monitoring device
10
Description
Mean Arterial Blood Pressure
Timepoint
Before surgery, every 15 minutes during the anesthesia, on arrival to the recovery room and then every 15 minutes
Method of measurement
Non invasive blood pressure measurement
11
Description
Recovery length
Timepoint
On arrival to the recovery room and then every 15 minutes till recovery room
Method of measurement
Watch or clock
Secondary outcomes
1
Description
Nausea
Timepoint
Recovery length
Method of measurement
Questioning
2
Description
Vomiting
Timepoint
Recovery length
Method of measurement
Observing
3
Description
Itching
Timepoint
Recovery length
Method of measurement
Questioning
4
Description
Atropine taken dose
Timepoint
Since the beginning of the operation until the end of the recovery length
Method of measurement
Asking from the anesthesia technician
5
Description
Pethidine taken dose
Timepoint
Since the beginning of the operation until the end of the recovery length
Method of measurement
Asking from the anesthesia technician
6
Description
Ephedrine taken dose
Timepoint
Since the beginning of the operation until the end of the recovery length
Method of measurement
Asking from the anesthesia technician
Intervention groups
1
Description
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.
Category
Prevention
2
Description
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.
Category
Prevention
3
Description
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.
Category
Prevention
4
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Behzad Nazemroaya
Street address
Soffeh boulevard, Shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahsa heydari
Street address
Esfahan University of Medical SciencesHezar Jarib Ave
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahsa Heydari
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Esfahan University of Medical Sciences,Hezar Jarib Ave
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
heydari72.mahsa@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemroaya
Position
Professor assistant of Anesthesia and Intensive carentensive care