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Efficacy of low-dose naloxone for the prevention of acute remifentanil-induced hyperalgesia

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20101122005225N8
Enrollment
75
Registered
2020-08-21
Start date
2017-08-23
Completion date
Unknown
Last updated
2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperalgesia.

Interventions

Intervention 1: 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. Intervention 2: Second

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.;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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Mohammad Mireskandari

Tehran University of Medical Sciences

mireskandari@sina.tums.ac.ir+98 21 6119 2828

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026