Determination of the effect of dexmedetomidine on postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy
Design
This double-blind clinical trial began with the approval of the University Ethics Committee. Fifty female patients aged 20-50 years who were candidates for cholecystectomy under general anesthesia were randomly divided into two equal groups using random allocation. The study was a double-blind study and the outcome assessor was unaware that the patient belonged to the intervention group or normal saline (control group).
Settings and conduct
Imam Khomeini Hospital started the operation and before cutting the skin to insert a laparoscope device in the study group dexmedetomidine, at a dose of 0.8 μg / kg in 100 cc of normal saline for ten minutes and in the control group 100 cc of serum N / S was infused under the same conditions .
Participants/Inclusion and exclusion criteria
50 patients 50-20 years old female candidates for cholecystectomy under general anesthesia
Inclusion criteria included adult patients with physical condition I-II of the American Society of Anesthesiologists (ASA) undergoing laparoscopic cholecystectomy for acute and chronic cholecystitis
Exclusion criteria included drug sensitivity in the study, receiving antiemetic drugs in the last 48 hours before surgery and body mass index above 35 kg / m2, surgery more than 2 hours, other concomitant surgery, complications during or after surgery and no Consent to participate in this study
Intervention groups
Dexmedetomidine study group
Normal saline group
Main outcome variables
Nausea / vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170411033365N2
Registration date:2021-11-10, 1400/08/19
Registration timing:retrospective
Last update:2021-11-10, 1400/08/19
Update count:0
Registration date
2021-11-10, 1400/08/19
Registrant information
Name
Alireza Mahoori
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 8967
Email address
mahouri.a@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-09-20, 1400/06/29
Actual recruitment start date
2021-06-23, 1400/04/02
Actual recruitment end date
2021-09-20, 1400/06/29
Trial completion date
2021-09-20, 1400/06/29
Scientific title
Assessment of the Dexmedetomidin effect on postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy
Public title
Assessment of the Dexmedetomidin effect on postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult Patients with Physical Status I-II of the American Society of Anesthesiologists (ASA) undergoing laparoscopic cholecystectomy for acute and chronic cholecystitis
Exclusion criteria:
Sensitivity to drugs in the study, receiving antiemetic drugs in the last 48 hours before surgery and body mass index above 35 kg / m2, surgery more than 2 hours, other concomitant surgery, complications during or after surgery and dissatisfaction with the company in this study
Age
From 20 years old to 50 years old
Gender
Female
Phase
1-2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly using computer numbers generated by Random allocation software in two groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and outcome assessors were unaware that the patient belonged to the intervention group or normal saline (control group). The outcome assessor was someone other than the person who had injected the drug and normal saline
Placebo
Used
Assignment
Parallel
Other design features
This double-blind clinical trial began with the approval of the University Ethics Committee. Conscious written consent was obtained from patients to participate in the study. Fifty patients aged 20-50 years old who were candidates for cholecystectomy under general anesthesia in two equal groups (25 patients in each group) in Imam Khomeini Hospital of Urmia affiliated to Urmia University of Medical Sciences were randomly generated using computer numbers. They were divided into two groups by Random allocation software.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IR.UMSU.REC.1400.113
Street address
بلوار آیت ا..مدرس-خیابان ارشاد
City
ارومیه
Province
West Azarbaijan
Postal code
5715789397
Approval date
2021-06-22, 1400/04/01
Ethics committee reference number
IR.UMSU.REC.1400.113
Health conditions studied
1
Description of health condition studied
Patients undergoing laparoscopic cholecystectomy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nausea / vomiting
Timepoint
recovery
Method of measurement
A score of zero was equivalent to no nausea or vomiting and a score of 5 was equivalent to the highest severity of nausea or vomiting.