Comparison of Remifentanil-induced Postoperative Hyperalgesia After Gynecological Laparoscopic Surgery Between Patients From the Plain Area and the Plateau Area
Overview
- Phase
- Not Applicable
- Intervention
- plateau areas
- Conditions
- Pain, Postoperative
- Sponsor
- Tianjin Medical University General Hospital
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm
- Last Updated
- 4 years ago
Overview
Brief Summary
Purpose:
- To compare the incidence of postoperative hyperalgesia induced by remifentanil in patients undergoing gynecological laparoscopic surgery in plateau and plain areas
- 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.
Investigators
Guolin Wang
Professor
Tianjin Medical University General Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Arms & Interventions
Remifentanil-analgesia in plateau area patients
Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plateau area patients.
Intervention: plateau areas
Sufentanil-analgesia in plain area patients
Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plain area patients.
Intervention: Sufentanil injection
Sufentanil-analgesia in plain area patients
Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plain area patients.
Intervention: plain areas
Remifentanil-analgesia in plain area patients
Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plain area patients.
Intervention: Remifentanil Hydrochloride
Remifentanil-analgesia in plain area patients
Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plain area patients.
Intervention: plain areas
Sufentanil-analgesia in plateau area patients
Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plateau area patients.
Intervention: Sufentanil injection
Sufentanil-analgesia in plateau area patients
Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plateau area patients.
Intervention: plateau areas
Remifentanil-analgesia in plateau area patients
Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plateau area patients.
Intervention: Remifentanil Hydrochloride
Outcomes
Primary Outcomes
Mechanical Hyperalgesia Threshold on the Dominant Inner Forearm
Time Frame: 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 Outcomes
- 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)
- Cumulative Hydromorphone Consumption(48 hours after surgery)
- Occurrence of Side Effects(48 hours after surgery)