Comparison study of the preemptive of the two dose of dexmedetomidine (bolus and infusion) on post operative pain, nausea and vomiting for laparoscopic cholecystectomy
Comparative determination of the preemptive of the two dose of dexmedetomidine (bolus and infusion) on post operative pain, nausea and vomiting for laparoscopic cholecystectomy
Design
Clinical trial with control group, with parallel groups, double blind, randomized on 90 patients, Randomized Allocation software was used for randomization
Settings and conduct
This is a double blind study in which the patient and the interventional physician are blind, and it is collected from selected hospitals under the supervision of Isfahan University of Medical Sciences. We have a study group to which the bolus dose and infusion of dexmedetomidine are administered before surgery and the amount of pain, nausea and vomiting after surgery is compared.
Participants/Inclusion and exclusion criteria
Entry requirements
Candidate patients for surgery with an age range of 18 to 65 years and ASA 1,2
Non-entry requirements
Patients with BMI above 30, drug addiction, chronic use of painkillers and sleeping pills, and drug allergy
Intervention groups
Group A received intravenous dexmedetomidine at the rate of 1 microgram per kilogram of body weight as a bolus dose 20 minutes before induction of anesthesia, and then 0.5 microgram per kilogram of body weight was given as an infusion for 15 minutes.
Group B received intravenous dexmedetomidine at the rate of 1 microgram per kilogram of body weight as a bolus dose 20 minutes before induction of anesthesia, and then 0.7 microgram per kilogram of body weight was given as an infusion for 15 minutes.
Group C uses normal saline instead of dexmedetomidine.
Main outcome variables
Pain, nausea and vomiting after surgery
General information
Reason for update
Acronym
پره امپتیو، دکسمدتومیدین، درد و تهوع و استفراغ، کولهسیستکتومی لاپاراسکوپی
IRCT registration information
IRCT registration number:IRCT20101211005362N31
Registration date:2022-11-07, 1401/08/16
Registration timing:registered_while_recruiting
Last update:2022-11-07, 1401/08/16
Update count:0
Registration date
2022-11-07, 1401/08/16
Registrant information
Name
Mohammadreza Safavi
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1273 2659
Email address
safavi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-03-16, 1401/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison study of the preemptive of the two dose of dexmedetomidine (bolus and infusion) on post operative pain, nausea and vomiting for laparoscopic cholecystectomy
Public title
Comparison study of the pre emptive of the two dose of dexmedetomidine (bolus and infusion) on post operative pain, nausea and vomiting for laparoscopic cholecystectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patient candidate to be operated laparoscopic cholecystectomy
one and two ASA
age between 18 - 65 year
Patient consent to participate in the study
Exclusion criteria:
Drug addiction
History of dexmedetomidine allergy
People with a BMI above 30
Use of sleeping pills and analgesics chronically
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is based on simple random method that means, all the samples which are eligible to participate in the study will be included in the study until the sample size is completed. Then, the patients who entered the study will be randomly divided into three groups using the Randomize Allocation software.
Random Allocation software (version 2.0) will be used.
Sampling will be done by the method of 3 permutation blocks. In this way, we will have 15 blocks of 6 and each block contains 6 letters from A, C and B, including AABBCC-ABCABC-BCBACA-BABACC and etc. (three groups of 30). Each patient is given a card at random. The cards are in sealed envelopes and the anesthesiologist takes the envelopes in order and delivers them to the patients. People with card A receive intravenous dexmedetomidine at a rate of 1 μg per kg of body weight as a bolus dose 20 minutes before induction of anesthesia and then receive 0.5 μg per kg of body weight as an infusion over 15 minutes. People who have card B receive intravenous dexmedetomidine at the rate of 1 μg per kg of body weight as a bolus dose 20 minutes before induction of anesthesia and then 0.7 μg per kg of body weight as an infusion for 15 minutes. People who have card C routinely faint.
The person who collects the data does not know whether the data is related to group A, group B or group C.
Blinding (investigator's opinion)
Double blinded
Blinding description
The method of blinding in this study is that the drugs are used by coding method and with syringes of equal volume for all patients. Also, the first anesthesiologist injects the drug based on simple random method then data collection is done by the second anesthesiologist. In addition the patients and the interventionist doctor do not know about studied groups, during the research project.
Placebo
Used
Assignment
Parallel
Other design features
In a clinical trial study, we should compare the administration of two bolus doses and infusion of dexmedetomidine on pain, nausea and vomiting in patients undergoing laparoscopic cholecystectomy.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan university of medical science
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-03-26, 1401/01/06
Ethics committee reference number
IR.MUI.MED.REC.1401.007
Health conditions studied
1
Description of health condition studied
Pain, nausea and vomiting
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Comparison of the effect of different doses of dexmedetomidine on amount of pain.
Timepoint
The first hour of recovery every 15 minutes, then 6 hours later, every two hours, and then 12, 24 and 48 hours later is evaluated.
Method of measurement
Pain intensity based on VAS scoring system and severity of nausea and vomiting using PONV system
2
Description
Comparing the effect of different doses of dexmedetomidine on nausea severity
Timepoint
The first hour of recovery every 15 minutes, then 6 hours later every two hours, and then 12, 24 and 48 hours later is evaluated.
Method of measurement
The severity of nausea is measured using the PONV system
3
Description
Comparing the effect of different doses of dexmedetomidine on vomiting severity
Timepoint
The first hour of recovery every 15 minutes, then 6 hours later, every two hours, and then 12, 24 and 48 hours later is evaluated.
Method of measurement
The severity of vomiting is measured using the PONV system
Secondary outcomes
1
Description
blood pressure
Timepoint
The first hour of recovery is evaluated every 15 minutes, then 6 hours later, every two hours, and then 12, 24 and 48 hours later
Method of measurement
Blood pressure is measured using a sphygmomanometer
2
Description
heart beat
Timepoint
The first hour of recovery is evaluated every 15 minutes, then every two hours after 6 hours, and then 12, 24, and 48 hours later.
Method of measurement
Heart rate is measured using a pulse oximeter
3
Description
Blood oxygen level
Timepoint
The first hour of recovery is evaluated every 15 minutes, then every two hours after 6 hours, and then 12, 24, and 48 hours later.
Method of measurement
Blood oxygen is measured using a pulse oximeter
4
Description
amount of drugs
Timepoint
The first hour of recovery is evaluated every 15 minutes, then every two hours after 6 hours, and then 12, 24, and 48 hours later.
Method of measurement
Using the volume in cc used
Intervention groups
1
Description
Intervention group: Intravenous dexmedetomidine at a dose of 1 microgram per kilogram of body weight is given as a bolus dose 20 minutes before induction of anesthesia and then 0.5 micrograms per kilogram of body weight for infusion for 15 minutes.
Category
Treatment - Drugs
2
Description
Intervention group: Intravenous dexmedetomidine at a dose of 1 microgram per kilogram of body weight is given as a bolus dose 20 minutes before induction of anesthesia and then 0.7 micrograms per kilogram of body weight is infused for 15 minutes.
Category
Treatment - Drugs
3
Description
Control group: instead of dexmedetomidine, we use 10 cc of normal saline before induction of anesthesia.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Selected hospitals under the supervision of Isfahan University of Medical Sciences
Full name of responsible person
Elnaz Toulabi
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 918 255 3262
Email
elnaztoulabi17@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohammad Reza Safavi
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 913 315 2416
Email
safavi@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Mohammadreza Safavi
Position
Associate Professor of Anesthesia
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology and Critical Care Research Center,Isfahan University of Medical Sciences, Isfahan, Iran
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1625 5555
Fax
+98 31 1273 2659
Email
safavi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Safavi
Position
Associate Professor of Anesthesia
Latest degree
Specialist
Other areas of specialty/work
Street address
Anesthesiology and Critical Care Research Center,Isfahan University of Medical Sciences, Isfahan, Iran
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1625 5555
Fax
+98 31 1273 2659
Email
safavi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Safavi
Position
Professor of anesthesia
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
City
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
Province
Isfehan
Postal code
7174675731
Phone
+98 31 1273 2659
Fax
+98 31 1273 2659
Email
safavi@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD