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Evaluation of the efficacy of low-dose naloxone for the prevention of acute remifentanil-induced hyperalgesia in patients undergoing general anesthesia for hysterectomy

Protocol summary

Study aim
To evaluate the efficacy of adding low dose naloxone to intraoperative infusion of remifentanil in preventing the post-operative acute remifentanil induced hyperalgesia in laparotomic hysterectomy
Design
Randomized controlled, parallel groups, double blinded clinical trial, 75 patients undergoing , three groups of remifentanil-naloxone , remifentanil and control
Settings and conduct
After administration of pre-medication midazolam and fentanyl and lidocaine anesthesia was induced by propofol and atracurium After tracheal intubation, isoflurane and muscle relaxants are used for maintenance of anesthesia, when necessary. In this study, both the patients and the evaluators are blinded to the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: ASA I-III patients; aged between 18 to 75 years scheduled for elective hysterectomy Exclusion criteria ; uncontrolled diabetes mellitus, neurologic disorders, psychologic disorders which needs treatment, inflammatory and renal diseases, drug abuse, routine use or taking NSAIDs, opioids, allergy or contraindication to anesthetic agents or pain medications, history of any type of chronic pain needs medical or interventional treatments and patients receiving ketamine, antipsychotic or gabapentinoids
Intervention groups
Remifentanil-Naloxone (patients receiving remifentanil 0.3 µg/kg/min and low dose naloxone 0.25 µg/kg/h in 50 ml normal saline, Remifentanil ( patients receiving remifentanil 0.3 µg/kg/min), and control (patients receiving an infusion of 50 ml normal saline
Main outcome variables
The severity of hyperalgesia and allodynia is assessed by static tactile tests. The severity of pain in a static tactile test is reported as VAS. Patients are asked to grade their highest pain severity from 1 to 10 in 0.5, 1, 6,12, and 24 hours after surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101122005225N8
Registration date: 2020-08-21, 1399/05/31
Registration timing: retrospective

Last update: 2020-08-21, 1399/05/31
Update count: 0
Registration date
2020-08-21, 1399/05/31
Registrant information
Name
Seyed mohammad Mireskandari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 8931
Email address
mireskandari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of low-dose naloxone for the prevention of acute remifentanil-induced hyperalgesia in patients undergoing general anesthesia for hysterectomy
Public title
Efficacy of low-dose naloxone for the prevention of acute remifentanil-induced hyperalgesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Female patients aged between 18 to 75 years ASA (American Society of Anesthesiologists) I-II patients Patients scheduled for elective hysterectomy
Exclusion criteria:
Uncontrolled diabetes mellitus Neurologic disorders Psychologic disorders which needs treatment Inflammatory and renal diseases Drug abuse Routine use or taking NSAIDs, opioids or other analgesics 48 hours prior to surgery Allergy or contraindication to anesthetic agents or pain medications, including NSAID’s, acetaminophen and opioids History of any type of chronic pain needs medical or interventional treatments Patient who develop any surgical or anesthetic complication, or need reoperation Patients receiving ketamine, antipsychotic or gabapentinoids
Age
From 18 years old to 75 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomlely assigned into three equal groups using computer-generated random sequence and the sealed envelope method by an assistant not involved in the study
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, both the patients and the evaluators were blinded to the type of intervention. All drugs were labeled and similar in appearance. A trained nurse anesthetist collects the data in operating room and post anesthetic care unit and an anesthesia resident blinded to study groups collects the data in the ward
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Vice Research office, Building no.1, Northern gate of the university, Poursina St. Qods St. Enqelab St.
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2016-04-23, 1395/02/04
Ethics committee reference number
IR.TUMS.REC.1395.2450

Health conditions studied

1

Description of health condition studied
Hyperalgesia
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
To decrease post operative hyperalgesia assessed by static tactile tests. The severity of pain in a static tactile test was reported as VAS
Timepoint
0.5, 2, 6, 12, and 24 hours after surgery.
Method of measurement
Static tactile test using a fine brush

Secondary outcomes

1

Description
Total morphin dose used in post operative period
Timepoint
During the 24 hour period after surgery
Method of measurement
Reported in Mg showed by analgesia pump

2

Description
The time of first rescue dose of morphine in post operative period
Timepoint
In post operative period
Method of measurement
It is reported as the time interval to the end of surgery

Intervention groups

1

Description
first Intervention group (Remifentanil-Naloxone group ):patients receiving remifentanil 0.3 µg/kg/min and low dose naloxone 0.25 µg/kg/h in 50 ml normal saline
Category
Treatment - Drugs

2

Description
Second Intervention group(Remifentanil ): patients receiving remifentanil 0.3 µg/kg/min)
Category
Treatment - Drugs

3

Description
Control group(control) : patients receiving an infusion of 50 ml normal saline
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Seyed Mohammad Mireskandari
Street address
Kheshavarz Boulvard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2828
Email
mireskandari@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
Gods Avenue, Keshavarz Boulvard, Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
1
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
Tehran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Mireskandari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Keshavarz Boulvard , Imam Khomeini hospital complex,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2828
Email
mireskandari@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Mireskandari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital Complex, Keshavarz Boulvard, Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2828
Email
mireskandari@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Mireskandari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Khomeini Hospital Complex, Keshavarz Boulvard, Tehran, iran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2828
Email
mireskandari@sina.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Undecided - It is not yet known if there will be 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
IPD collected for the primary outcome measure only
When the data will become available and for how long
starting in November 2025
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
only for academic and research goals
From where data/document is obtainable
Via sending an Email for corresponding researcher
What processes are involved for a request to access data/document
proposal of the project and document of it's registration
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