Study of the effect of different doses of Naloxone on postoperative hyperalgesia in patients receiving high-dose RemiFentanyl in hysterectomy surgeries
Determining the efficacy of different doses of naloxone on hyperalgesia after surgery in patients receiving high-dose Remi Fentanyl in hysterectomy surgeries
Design
Clinical trial with control group, parallel groups, double blind, randomized with 30 patients
Settings and conduct
Patients with hysterectomy candidates who underwent surgery at Rasoul Akram Hospital. They are anesthetized with naloxone. Participants are randomly assigned to three groups. Also, participants and assessors of the outcome will not be aware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients candidate for hysterectomy, َASA 1&2, No drug allergy؛ Exclusion criteria: addiction, َََalcohol consumption
Intervention groups
Control group: Normal saline with a dose of 0.2 cc per kg
Intervention Group 1: Naloxone Infusion with a dose of 0.05 μg / kg / min
Intervention Group 2: Naloxone Infusion with a dose of 0.02 μg / kg / min
Main outcome variables
VAS, Ramsy score, Pinprick test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180723040570N5
Registration date:2020-06-27, 1399/04/07
Registration timing:prospective
Last update:2020-06-27, 1399/04/07
Update count:0
Registration date
2020-06-27, 1399/04/07
Registrant information
Name
Nasim Nikoubakht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 9854
Email address
nikoobakht.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-21, 1399/04/31
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of different doses of Naloxone on postoperative hyperalgesia in patients receiving high-dose RemiFentanyl in hysterectomy surgeries
Public title
Effects of different doses of Naloxone on postoperative hyperparathyroidism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for hysterectomy
َASA 1&2
No drug allergy
Exclusion criteria:
Addiction
َََAlcohol consumption
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, all eligible patients were assigned to three groups using random sequence extraction from the computer (via www.randomization.com) and simple randomization. The resulting random numbers, i.e. the allocation of patients to groups, was concealed using sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and outcome assessors are unaware of the type of group and the type of intervention
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
Iran University of Medical Sciences, Milad tower, Hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-01-28, 1398/11/08
Ethics committee reference number
IR.IUMS.FMD.REC.1398.483
Health conditions studied
1
Description of health condition studied
Hysterectomy
ICD-10 code
N99.3
ICD-10 code description
Prolapse of vaginal vault after hysterectomy
Primary outcomes
1
Description
Visual Analogue Scale
Timepoint
30 minutes before surgery and 1, 2 , 8 and 24 hours after surgery
Method of measurement
Patient's answer
2
Description
Ramsy score
Timepoint
30 minutes before surgery and 1, 2 , 8 and 24 hours after surgery
Method of measurement
Patient's answer
3
Description
Pinprick test
Timepoint
30 minutes before surgery and 1, 2 , 8 and 24 hours after surgery
Method of measurement
Patient's answer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Naloxone infusion with a dose of 0.05 μg / kg / min will be arranged by the completion of the surgery. Naloxone is produced by "Tolid daro" company of Iran.
Category
Treatment - Drugs
2
Description
Intervention group 2: Naloxone Infusion with a dose of 0.02 μg / kg / min will be arranged by the completion of the surgery. Naloxone is produced by "Tolid daro" company of Iran.
Category
Treatment - Drugs
3
Description
Control group: Normal saline with a dose of 0.2 cc per kg will be injected instead of Naloxone.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Rasoole Akram hospital
Full name of responsible person
Nasim Nikoobakht
Street address
Satarkhan St
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1000
Email
nnikobakht@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Abbas Motavalian
Street address
Iran University of Medical Sciences, Milad tower, Hemmat highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1000
Email
amotevalian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Nasim Nikoubakht
Position
Assistant, Professor,
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Rasool Akram, Maziar Mansory Ave, Satarkhan Ave.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 64351
Email
Nikoobakht.n@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasim Nikoubakht
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.24, Kashfian Ave., Sheykhbahayy Ave., Molasadra Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 9854
Fax
Email
nikoobakht.n@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasim Nikoubakht
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No.24, Kashfian Ave., Sheykhbahayy Ave., Molasadra Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 9854
Fax
Email
nikoobakht.n@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All individual data of the participants in this study will be shared after unidentifiable individuals
When the data will become available and for how long
The access period will start from 2021to 2022
To whom data/document is available
Data will be available to researchers working in the university.
Under which criteria data/document could be used
Just for performing research
From where data/document is obtainable
Refer to the responsible person for accessing the data
What processes are involved for a request to access data/document
The data will be available one month after the responsible person's approval