Comparing the effect of oral clonidine and metoclopramide on intraoperative hemodynamic parameters, nausea, and vomiting after laparoscopic cholecystectomy
Comparing the effect of oral clonidine and metoclopramide on intraoperative hemodynamic parameters, nausea, and vomiting after laparoscopic cholecystectomy
Design
This randomized-controlled parallel, triple-blind clinical trial study, phase 3 will be conducted on 75 patients. The randomization will be done with a stratified block randomization method using random allocation software.
Settings and conduct
In this triple-blind clinical trial study, the patients undergoing elective laparoscopic cholecystectomy in Urmia Imam Khomeini hospital will be enrolled. Patients will be divided into interventions or placebo groups using stratified block randomization. Patients will receive oral clonidine 400 micrograms (group 1), oral metoclopramide 10 mg (group 2), and placebo (group 3) 90 minutes before induction.
Participants/Inclusion and exclusion criteria
In this study, the patients undergoing elective laparoscopic cholecystectomy
with the physical status of one and two according to the American Society of Anesthesiology (ASA I and ASA II) and ages 20 to 60 years will be enrolled. The exclusion criteria will be including hypertension, diabetic patients, cardiovascular diseases, asthma disease, and allergy to clonidine and metoclopramide.
Intervention groups
Patients will receive oral clonidine 400 micrograms (group 1), oral metoclopramide 10 mg (group 2), and placebo (group 3) 90 minutes before induction.
Main outcome variables
The primary outcomes will be hemodynamic parameters and nausea and vomiting.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210919052515N4
Registration date:2022-04-12, 1401/01/23
Registration timing:prospective
Last update:2022-04-12, 1401/01/23
Update count:0
Registration date
2022-04-12, 1401/01/23
Registrant information
Name
Naser Masoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3337 9924
Email address
masoudi.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of oral clonidine and metoclopramide on intraoperative hemodynamic parameters, nausea, and vomiting after laparoscopic cholecystectomy
Public title
Evaluation of the effect of oral clonidine and metoclopramide after laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing elective laparoscopic cholecystectomy
Patients with the physical status of one and two according to the American Society of Anesthesiology (ASA I and ASA II)
Age 20 to 60 years
Exclusion criteria:
Hypertension
Diabetic patients
Cardiovascular diseases
Asthma disease
Allergy to clonidine and metoclopramide
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention and placebo groups using stratified block randomization based on generated numbers by random allocation software. Firstly, patients will be stratified according to sex, and then randomization will be performed in each stratum. So that, in this software, the number of groups and the total number of the sample size will be entered firstly, and then in the block section, the block randomization method will be implemented. Patients will be allocated to intervention or placebo groups based on generated numbers.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study will be conducted as a triple-blind clinical trial. The patient, the researcher who will be evaluating the outcomes, and the data Analyzer will be blinded to the intervention or placebo groups. The drugs will be given to the patient by a nurse in the ward. The names of the groups will be coded to the data analyzer.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Imam Khomeini university hospital- Urmia University of Medical Sciences
During induction, 5 minutes, 10 minutes after intubation, during skin incision, 15 and 30 minutes after pneumonia, 30 minutes after pneumonia release
Method of measurement
Monitoring
2
Description
Systolic blood pressure
Timepoint
During induction, 5 minutes, 10 minutes after intubation, during skin incision, 15 and 30 minutes after pneumonia, 30 minutes after pneumonia release
Method of measurement
Monitoring
3
Description
Diastolic blood pressure
Timepoint
During induction, 5 minutes, 10 minutes after intubation, during skin incision, 15 and 30 minutes after pneumonia, 30 minutes after pneumonia release
Method of measurement
Monitoring
4
Description
Mean arterial pressure (MAP)
Timepoint
During induction, 5 minutes, 10 minutes after intubation, during skin incision, 15 and 30 minutes after pneumonia, 30 minutes after pneumonia release
Method of measurement
Monitoring
5
Description
Nausea
Timepoint
At the end of surgery
Method of measurement
Yes/No
6
Description
Vomiting
Timepoint
At the end of surgery
Method of measurement
Yes/No
Secondary outcomes
1
Description
Complications
Timepoint
At the end of surgery
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group: Patients will receive one tablet of oral clonidine of 200 micrograms (group 1), 90 minutes before induction. Clonidine will be provided by Tolid Darou pharmaceutical company.
Category
Treatment - Other
2
Description
Intervention group: Patients will receive one tablet of oral metoclopramide 10 mg (group 2), 90 minutes before induction. metoclopramide will be provided by Amin Pharmaceutical Company.
Category
Treatment - Other
3
Description
Control group: Patients will receive placebo (group 3) 90 minutes before induction.