Comparison of intraoperative opioid use in two opioid injections according to the pain score determined by the Analgesia nociception index (ANI) and conventional injections in laparoscopic gynecological surgery
Comparison of total intraoperative opioid use in two methods of opioid injection based on pain score determined by the Analgesia nociception index (ANI) device and injection with conventional method in laparoscopic gynecological surgeries in women
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 1 on 90 patients
Settings and conduct
Study place: Rasool Akram hospital; Type of blinding: double-blind; How to blind: The patient and the statistical analyzer are unaware of which analgesic method the patient has been used for analgesia.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate of laparoscopic gynecological surgery, Age between 18-45 years, Body mass index (BMI) less than 25.
Non-inclusion criteria: Having cardiac arrhythmia, Patients with central or autonomic neurological problems undergoing opioid treatment
Intervention groups
Intervention group: Opioid injection based on pain score determined by the device (Analgesia nociception index (ANI).
Control group: Opioid injection with conventional method
Main outcome variables
Total dose of opioid used, pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120814010599N30
Registration date:2021-09-20, 1400/06/29
Registration timing:registered_while_recruiting
Last update:2021-09-20, 1400/06/29
Update count:0
Registration date
2021-09-20, 1400/06/29
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9059
Email address
p-rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-20, 1400/05/29
Expected recruitment end date
2022-02-18, 1400/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intraoperative opioid use in two opioid injections according to the pain score determined by the Analgesia nociception index (ANI) and conventional injections in laparoscopic gynecological surgery
Public title
Comparison of intraoperative opioid use in two opioid injections by Analgesia nociception index (ANI) and conventional method
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate of laparoscopic gynecological surgery
Age between 18-45 years
Body mass index (BMI) less than 25
Exclusion criteria:
Having cardiac arrhythmia
Patients with central or autonomic neurological problems undergoing opioid treatment
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into two groups of analgesia with Analgesia nociception index(ANI) and conventional method using random allocation software. By selecting the simple randomization method in the randomization box and entering the determined total sample size in this software, numbers were given to the patients and the patients were allocated into two groups according to computer-generated numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the statistical analyzer were unaware of the analgesia methods the patient is using. Analgesia was performed by an anesthesiologist in the operating room for randomly selected patients. In this way, the patient was only aware of the analgesia being performed on him/her but was unaware of its type and also the statistical analyzer will receive the data in code A and B for the intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences.
Street address
Vice chancellor for research, Iran University of Medical Sciences, beside Milad Tower, Hemat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-05-17, 1400/02/27
Ethics committee reference number
IR.IUMS.FMD.REC.1400.145
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Total dose of opioid used during surgery
Timepoint
After surgery
Method of measurement
Patient file
Secondary outcomes
1
Description
Pain
Timepoint
At 1, 12 and 24 hours after surgery
Method of measurement
Visual analog scale
Intervention groups
1
Description
Intervention group: In the Analgesia nociception index (ANI) intervention group, control for analgesia of patients during the operation of remifentanil (Produced by Exir) will be performed according to the pain score determined by the Analgesia nociception index (ANI) device. In the ANl group, two electrodes will be placed on the sternum and the left mid axillary line. Total remifentanil consumption was recorded as micrograms. Intraoperative pain measurement will be performed with the same device that measures pain score under anesthesia. It should be noted that pain score is scored by analyzing by the device. The device will be continuously connected to the patient and in case of changes beyond the desired range, the patient will be injected with medication.
Category
Treatment - Drugs
2
Description
Control group: In this group conventional method will be done (drug injection if the patient expresses pain)