Comparison of Remifentanil-induced Postoperative Hyperalgesia Between Patients From Plain Area and Plateau Area

NCT05028049 | Unknown DMC

• 1 other identifier: GWang014
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

Purpose:

1. 1.To compare the incidence of postoperative hyperalgesia induced by remifentanil in patients undergoing gynecological laparoscopic surgery in plateau and plain areas
2. 2.To compare the peri-operative analgesic requirements of patients in plain and plateau areas

Conditions

Pain, Postoperative; Anesthesia

Keywords

Remifentanil; Opioid-induced hyperalgesia; Postoperative pain; pain intensity

Outcome Measures

Primary Outcomes (1)

• Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm

  The mechanical hyperalgesia threshold was defined as the lowest force (g) necessary to bend a Von Frey filament, which was perceived to be painful by the patient and measured by Von Frey filament after surgery

  48 hours after surgery

Secondary Outcomes (7)

• Pain Score (NRS)

  48 hours after surgery

• Normalized Area of Hyperalgesia Around the Incision

  48 hours after surgery

• Mechanical hyperalgesia threshold around the incision

  48 hours after surgery

• Time of First Postoperative Analgesic Requirement

  1 hour after surgery

• Total Dose of First Postoperative Analgesic Requirement

  1 hour after surgery

Study Arms (4)

Sufentanil-analgesia in plain area patients

Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plain area patients.

Drug: Sufentanil injection; Other: plain areas

Remifentanil-analgesia in plain area patients

Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plain area patients.

Drug: Remifentanil Hydrochloride; Other: plain areas

Sufentanil-analgesia in plateau area patients

Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plateau area patients.

Drug: Sufentanil injection; Other: plateau areas

Remifentanil-analgesia in plateau area patients

Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plateau area patients.

Drug: Remifentanil Hydrochloride; Other: plateau areas

Interventions

Sufentanil injection DRUG

Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia

Also known as: Sufentanil

Sufentanil-analgesia in plain area patients; Sufentanil-analgesia in plateau area patients

Remifentanil Hydrochloride DRUG

Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia

Also known as: Remifentanil

Remifentanil-analgesia in plain area patients; Remifentanil-analgesia in plateau area patients

plain areas OTHER

Patients should be long staying residents in plain areas (altitude level below 1,000 meters above sea level)

Remifentanil-analgesia in plain area patients; Sufentanil-analgesia in plain area patients

plateau areas OTHER

Patients should be long staying residents in plateau areas (altitude level\>3000 meters above sea level)

Remifentanil-analgesia in plateau area patients; Sufentanil-analgesia in plateau area patients

Eligibility Criteria

• Age: 20 Years - 60 Years
• Gender Eligibility Details: We selected female patients which will receive gynecological laparoscopic surgery
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients in plateau areas are long staying residents in above 3000 meters above sea level for enrollment, while patients in plain areas are long staying residents below 1000 meters above sea level.

You may qualify if:

• Subject is scheduled to undergo gynecological laparoscopic surgery under a short general anesthesia of less than 2 hours
• Subject's American Society of Anesthesiologists physical status is I-II.
• The subject's parent/legally authorized guardian has given written informed consent to participate.
• Patients in plateau areas are long staying residents in above 3000 meters above sea level for enrollment, while patients in plain areas are long staying residents below 1000 meters above sea level.

You may not qualify if:

• Subject has a diagnosis of renal or liver failure.
• Subject has a diagnosis of Insulin dependent diabetes.
• Subject is allergy and contraindication to any drugs used during general anesthesia.
• Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre-existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
• Subject has any contraindication for the use of patient-controlled analgesia (PCA).
• Subject is pregnant or breast-feeding.
• Subject is obese (body mass index \>30kg/m2).

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (2)

Gannan Tibetan Autonomous Prefecture People's Hospital

Hezuo, Gansu, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Sufentanil; Remifentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Guolin Wang, MD

  Tianjin Medical University General Hospital

  STUDY DIRECTOR

Central Study Contacts

Guolin Wang, MD

CONTACT

+8618604755166; wangguolinghad@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2021
• First Posted: August 31, 2021
• Study Start: August 30, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 31, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)