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

• Conditions: Pain, Postoperative; Anesthesia
• Interventions: Drug: Sufentanil injection; Drug: Remifentanil Hydrochloride; Other: plain areas; Other: plateau areas

• Registration Number: NCT05028049
• Lead Sponsor: Tianjin Medical University General Hospital

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.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-21
• Study First Submitted QC: 2021-08-28
• Last Update Submitted: 2021-08-28
• Study Start: 2021-08-30
• Study First Posted: 2021-08-31
• Last Update Posted: 2021-08-31
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sufentanil-analgesia in plain area patients	Sufentanil injection	Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plain area patients.
Sufentanil-analgesia in plain area patients	plain areas	Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plain area patients.
Remifentanil-analgesia in plain area patients	Remifentanil Hydrochloride	Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plain area patients.
Remifentanil-analgesia in plain area patients	plain areas	Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plain area patients.
Sufentanil-analgesia in plateau area patients	plateau areas	Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plateau area patients.
Remifentanil-analgesia in plateau area patients	Remifentanil Hydrochloride	Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plateau area patients.
Remifentanil-analgesia in plateau area patients	plateau areas	Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia in plateau area patients.
Sufentanil-analgesia in plateau area patients	Sufentanil injection	Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia in plateau area patients.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
Time of First Postoperative Analgesic Requirement	1 hour after surgery	First postoperative pain (NRS≥5) is initially controlled by titration of Hydromorphone.
Total Dose of First Postoperative Analgesic Requirement	1 hour after surgery	First postoperative pain (NRS≥5) is initially controlled by titration of Hydromorphone.
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
Occurrence of Side Effects	48 hours after surgery	Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus

Trial Locations

Locations (2)

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, China

Gannan Tibetan Autonomous Prefecture People's Hospital; 🇨🇳 Hezuo, Gansu, China