Comparison of general anesthesia and low dose spinal anesthesia in hysteroscopy on postoperative pain, nausea and vomiting
Design
Study groups:
A group that has undergone hysteroscopy under general anesthesia
The group underwent hysteroscopic spinal anesthesia under low dose.
Sample size: 88 people in two groups of 44 people
Random clinical trial with two control groups
Two-way blind
Parallel groups
Random assignment of all samples with spss software
Settings and conduct
A total of 88 hysteroscopic candidates in Shahid Beheshti Hospital in Isfahan are randomly assigned to one of the two groups of general anesthesia and low dose spinal. Postoperatively during the first 15 minutes of entry into recovery, at the time of discharge from recovery and 4 hours after surgery; The presence or absence of nausea and vomiting is assessed and their pain is assessed by the VAS criterion.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. In terms of anesthesia in II and I ASA
2. Satisfaction to enter the study
3- Age between 18-60 years
4. Candidate patients for hysteroscopic surgery based on the opinion of a gynecologist
Exclusion criteria: Drug use, use of antidepressants, pregnancy, heart disease, hypothyroidism and hyperthyroidism, sensitivity to anesthetic drugs, severe bleeding during surgery, severe hemodynamic disorders, allergic symptoms and acute pelvic infection The study will be out
Intervention groups
One group underwent general anesthesia and the other group underwent low-dose spinal hysteroscopy.
Main outcome variables
Distribution of relative frequency of postoperative vomiting
Distribution of relative frequency of postoperative nausea
Frequency distribution of mean postoperative pain score by VAS criterion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120201008897N9
Registration date:2021-05-23, 1400/03/02
Registration timing:registered_while_recruiting
Last update:2021-05-23, 1400/03/02
Update count:0
Registration date
2021-05-23, 1400/03/02
Registrant information
Name
Safoura Rouholamin
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1236 7001
Email address
s_rouholamin@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of general anesthesia and low dose spinal anesthesia in hysteroscopy on postoperative pain, nausea and vomiting
Public title
Comparative study of general anesthesia and low dose spinal anesthesia in hysteroscopic patients on postoperative pain, nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for hysteroscopy based on the opinion of a gynecologist
In terms of anesthesia in II and I ASA
Consent to enter the study
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of all studied samples or using SPSS randomization software is done.
Method: Simple randomization
Unit: Individual
Tools: Statistical software
Layered randomization: None
Hiding: All samples studied or using SPSS randomization software is done.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, only the person who collects the information and also the person who performs the statistical analysis are unaware of the study groups.
Placebo
Not 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 Hezar Jerib St. Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-04-25, 1400/02/05
Ethics committee reference number
IR.MUI.MED.REC.1400.038
Health conditions studied
1
Description of health condition studied
Candidates for hysteroscopy based on the opinion of a gynecologist
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score based on Visual Analogue scale - nausea and vomiting
Timepoint
The first 15 minutes of recovery - when discharge - 4 hours after surgery
Method of measurement
Patient pain rate based on Visual analoguse scale - nausea and vomiting based on patient question (yes - no)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People undergoing general hysteroscopy under general anesthesia
Category
Treatment - Surgery
2
Description
Intervention group: People undergoing low-dose spinal hysteroscopy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
shahid beheshti hospital
Full name of responsible person
safoura rouholamin
Street address
Isfahan - Ostad Motahhari Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 5554 0029
Email
s_rouholamin@med.mui.ac.r
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
safoura rouholamin
Street address
Isfahan Hezar Jerib Street
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
s_rouholamin@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
safoura rouholamin
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3663 9903
Email
s_rouholamin@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
safoura rouholamin
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan Hezar Jerib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3663 9903
Email
s_rouholamin@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
safoura rouholamin
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan Hezar Jerib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3663 9903
Email
s_rouholamin@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
No; The data will not be shared separately, but the results of their analysis will be shared in the article