This study is a double-blind randomized clinical trial, on 80 patients, with the aim of survey Compare the Ketofol and Sodium thiopental in General anesthesia patients undergoing dilatation and curettage in Alavi hospital from 2016 will be done. Inclusion criteria including Vaginal bleeding, patients suspected to have an abortion, Patients candidate of uterine curettage, consent to participate in the study and exclusion criteria included contraindication to uterine curettage, sensitivity to Ketofol and Sodium thiopental, conversion. Patients randomly with using random numbers table will be divided into two groups of 40 Patients and Intraoperative the first group Ketofol(Half milligrams per weight ketamine and One mg per Kg of propofol) and to second group 3 mg per Kg Sodium thiopental will be injected. Intraoperative, unaware questioner will be survey change of hemodynamic and respiratory disorders as the primary outcome and patient satisfaction with anesthesia and surgeon satisfaction after surgery will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017031923559N9
Registration date:2017-04-24, 1396/02/04
Registration timing:na
Last update:
Update count:0
Registration date
2017-04-24, 1396/02/04
Registrant information
Name
Somaieh Matin
Name of organization / entity
Ardabil University of Medicine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3373 3011
Email address
s.matin@arums.ac.ir
Recruitment status
Not enough for processing
Funding source
Vice chancellor for research, Ardabil University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
empty
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the Ketofol and Sodium thiopental in General anesthesia patients undergoing dilatation and curettage in Alavi hospital from 2016
Public title
Compare the Ketofol and Sodium thiopental in General anesthesia patients undergoing dilatation and curettage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Vaginal bleeding; patients suspected to have an abortion; Patients candidate of uterine curettage; consent to participate in the study.
Exclusion criteria: contraindication to uterine curettage; sensitivity to Ketofol and Sodium thiopental
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study divided patients into two groups and will be used by Table of random numbers. Classification of patients will be done by operator and anesthesia technician that injects the drug is not aware of the type of drugs.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medicine Sciences, Daneshgah street, Ardabil
City
Ardabil
Postal code
53141-56198
Approval date
2016-10-03, 1395/07/12
Ethics committee reference number
IR.ARUMS.REC.1395.55
Health conditions studied
1
Description of health condition studied
Surgical abortion
ICD-10 code
O08.1
ICD-10 code description
Complete or unspecified, complicated by delayed or excessive haemorrhage
Primary outcomes
1
Description
Apnea
Timepoint
Intraoperative
Method of measurement
Based on the patient's respiratory status
Secondary outcomes
1
Description
Patient satisfaction of anesthesia
Timepoint
Intraoperative
Method of measurement
question of patient
2
Description
Decreased oxygen saturation
Timepoint
Intraoperative
Method of measurement
According to pulse oximetry
Intervention groups
1
Description
The first group injected Ketofol that contains a half milligrams per kilogram of ketamine and 1 mg per kg body weight propofol before the surgery.
The second group of three milligrams per kilogram of sodium thiopental injected before the surgery.