Clinical trial NCT05028049: Comparison of Remifentanil-induced Postoperative Hyperalgesia Between Patients From Plain Area and Plateau Area
Official title: Comparison of Remifentanil-induced Postoperative Hyperalgesia After Gynecological Laparoscopic Surgery Between Patients From the Plain Area and the Plateau Area
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain, Postoperative
Anesthesia
Keywords: Remifentanil
Opioid-induced hyperalgesia
Postoperative pain
pain intensity
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 160
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Pain Score (NRS)
timeFrame: 48 hours after surgery
measure: Normalized Area of Hyperalgesia Around the Incision
timeFrame: 48 hours after surgery
measure: Mechanical hyperalgesia threshold around the incision
timeFrame: 48 hours after surgery
measure: Time of First Postoperative Analgesic Requirement
timeFrame: 1 hour after surgery
measure: Total Dose of First Postoperative Analgesic Requirement
timeFrame: 1 hour after surgery
measure: Cumulative Hydromorphone Consumption
timeFrame: 48 hours after surgery
measure: Occurrence of Side Effects
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Hezuo
country: China
facility: Gannan Tibetan Autonomous Prefecture People's Hospital
state: Gansu
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
Study officials:
affiliation: Tianjin Medical University General Hospital
name: Guolin Wang, MD
role: STUDY_DIRECTOR
References: