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

NCT ID: NCT05028049

Last Updated: 2021-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-30

Study Completion Date

2021-12-31

Brief Summary

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Purpose:

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

Detailed Description

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Our research group has been committed to the research of remifentanil-induced hyperalgesia for a long time. In the previous study, it was found that intraoperative infusion of remifentanil (0.3ug/kg•min) \>1h can lead to remifentanil-induced hyperalgesia and the incidence rate is relative high in the plain area. Due to the long-term low pressure and hypoxia of people living in plateau areas, a series of changes will occur in the respiratory and circulatory systems, and their anesthesia management needs to be adjusted accordingly. However, there is no relevant research on whether or not hyperalgesia occurs in people in plateau areas (altitude level \>3000 meters). Therefore, this study hopes to compare the incidence and degree of remifentanil-induced hyperalgesia after gynecological laparoscopic surgery in plain areas and plateau areas.

Conditions

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Pain, Postoperative Anesthesia

Keywords

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Remifentanil Opioid-induced hyperalgesia Postoperative pain pain intensity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sufentanil-analgesia in plain area patients

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

Sufentanil injection

Intervention Type DRUG

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

plain areas

Intervention Type 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

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

Remifentanil Hydrochloride

Intervention Type DRUG

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

plain areas

Intervention Type OTHER

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

Sufentanil-analgesia in plateau area patients

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

Sufentanil injection

Intervention Type DRUG

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

plateau areas

Intervention Type OTHER

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

Remifentanil-analgesia in plateau area patients

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

Remifentanil Hydrochloride

Intervention Type DRUG

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

plateau areas

Intervention Type OTHER

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

Interventions

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Sufentanil injection

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

Intervention Type DRUG

Remifentanil Hydrochloride

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

Intervention Type DRUG

plain areas

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

Intervention Type OTHER

plateau areas

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

Intervention Type OTHER

Other Intervention Names

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Sufentanil Remifentanil

Eligibility Criteria

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Inclusion Criteria

1. Subject is scheduled to undergo gynecological laparoscopic surgery under a short general anesthesia of less than 2 hours
2. Subject's American Society of Anesthesiologists physical status is I-II.
3. The subject's parent/legally authorized guardian has given written informed consent to participate.
4. 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.

Exclusion Criteria

1. Subject has a diagnosis of renal or liver failure.
2. Subject has a diagnosis of Insulin dependent diabetes.
3. Subject is allergy and contraindication to any drugs used during general anesthesia.
4. 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.
5. Subject has any contraindication for the use of patient-controlled analgesia (PCA).
6. Subject is pregnant or breast-feeding.
7. Subject is obese (body mass index \>30kg/m2).
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guolin Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guolin Wang, MD

Role: STUDY_DIRECTOR

Tianjin Medical University General Hospital

Locations

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Gannan Tibetan Autonomous Prefecture People's Hospital

Hezuo, Gansu, China

Site Status

Tianjin Medical University General Hospital

Tianjin, , China

Site Status

Countries

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China

Central Contacts

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Guolin Wang, MD

Role: CONTACT

Phone: +8618604755166

Email: [email protected]

Facility Contacts

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Yonggang Lv, MD

Role: primary

Guolin Wang

Role: primary

Other Identifiers

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GWang014

Identifier Type: -

Identifier Source: org_study_id