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

Sponsor
Tianjin Medical University General Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05028049
Collaborator
(none)
160
2
4
80
19.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Sufentanil injection
  • Drug: Remifentanil Hydrochloride
  • Other: plain areas
  • Other: plateau areas

Detailed Description

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
160 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of Remifentanil-induced Postoperative Hyperalgesia After Gynecological Laparoscopic Surgery Between Patients From the Plain Area and the Plateau Area
Anticipated Study Start Date :
Aug 30, 2021
Anticipated Primary Completion Date :
Dec 15, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
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
Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia
Other Names:
  • Sufentanil
  • Other: plain areas
    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.

    Drug: Remifentanil Hydrochloride
    Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia
    Other Names:
  • Remifentanil
  • Other: plain areas
    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.

    Drug: Sufentanil injection
    Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia
    Other Names:
  • Sufentanil
  • Other: plateau areas
    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.

    Drug: Remifentanil Hydrochloride
    Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia
    Other Names:
  • Remifentanil
  • Other: plateau areas
    Patients should be long staying residents in plateau areas (altitude level>3000 meters above sea level)

    Outcome Measures

    Primary Outcome Measures

    1. Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm [48 hours after surgery]

      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

    Secondary Outcome Measures

    1. Pain Score (NRS) [48 hours after surgery]

      The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10= greatest imaginable pain.

    2. Normalized Area of Hyperalgesia Around the Incision [48 hours after surgery]

      The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a'painful', 'sore' or 'sharper' feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.

    3. Mechanical hyperalgesia threshold around the incision [48 hours after surgery]

      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.

    4. Time of First Postoperative Analgesic Requirement [1 hour after surgery]

      First postoperative pain (NRS≥5) is initially controlled by titration of Hydromorphone.

    5. Total Dose of First Postoperative Analgesic Requirement [1 hour after surgery]

      First postoperative pain (NRS≥5) is initially controlled by titration of Hydromorphone.

    6. Cumulative Hydromorphone Consumption [48 hours after surgery]

      Each patient was administered analgesics using a PCA (Patient-controlled analgesia) pump containing Hydromorphone (200μg) in normal saline at a total volume of 100 ml after leaving PACU (Postanesthesia care unit). This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5 ml with a 15-min lockout period. Hydromorphone cumulative consumption is recorded 48 hours postoperatively

    7. Occurrence of Side Effects [48 hours after surgery]

      Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gannan Tibetan Autonomous Prefecture People's Hospital Hezuo Gansu China
    2 Tianjin Medical University General Hospital Tianjin China 300052

    Sponsors and Collaborators

    • Tianjin Medical University General Hospital

    Investigators

    • Study Director: Guolin Wang, MD, Tianjin Medical University General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guolin Wang, Professor, Tianjin Medical University General Hospital
    ClinicalTrials.gov Identifier:
    NCT05028049
    Other Study ID Numbers:
    • GWang014
    First Posted:
    Aug 31, 2021
    Last Update Posted:
    Aug 31, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Guolin Wang, Professor, Tianjin Medical University General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 31, 2021