An observational study in Pain, Postoperative and Anesthesia, sponsored by Tianjin Medical University General Hospital. Status unknown at 2 sites in China. Open to female participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-08-31.
Sponsored by Tianjin Medical University General Hospital · Observational
Purpose:
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.
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:
Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plain area patients.
Drug: Sufentanil injection · Other: plain areas
Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plain area patients.
Drug: Remifentanil Hydrochloride · Other: plain areas
Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plateau area patients.
Drug: Sufentanil injection · Other: plateau areas
Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plateau area patients.
Drug: Remifentanil Hydrochloride · Other: plateau areas
Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia
Also known as: Sufentanil
Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia
Also known as: Remifentanil
Patients should be long staying residents in plain areas (altitude level below 1,000 meters above sea level)
Patients should be long staying residents in plateau areas (altitude level\>3000 meters above sea level)
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
Time frame: 48 hours after surgery
Pain Score (NRS)
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.
Time frame: 48 hours after surgery
Normalized Area of Hyperalgesia Around the Incision
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.
Time frame: 48 hours after surgery
Mechanical hyperalgesia threshold around the incision
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.
Time frame: 48 hours after surgery
Time of First Postoperative Analgesic Requirement
First postoperative pain (NRS≥5) is initially controlled by titration of Hydromorphone.
Time frame: 1 hour after surgery
Total Dose of First Postoperative Analgesic Requirement
First postoperative pain (NRS≥5) is initially controlled by titration of Hydromorphone.
Time frame: 1 hour after surgery
Cumulative Hydromorphone Consumption
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
Time frame: 48 hours after surgery
Occurrence of Side Effects
Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus
Time frame: 48 hours after surgery
Plan to share: No
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Tianjin Medical University General Hospital