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

Comparison of Remifentanil-induced Postoperative Hyperalgesia After Gynecological Laparoscopic Surgery Between Patients From the Plain Area and the Plateau Area

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative; Anesthesia
• Intervention / Treatment: Drug: Sufentanil injection; Other: plain areas; Drug: Remifentanil Hydrochloride; 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 Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

• Study Contact: Name: Guolin Wang, MD; Phone Number: +8618604755166; Email: wangguolinghad@hotmail.com

Study Locations

• China
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
    • Contact: Guolin Wang; Phone Number: +8618604755166
  • Gansu
    • Hezuo, Gansu, China
      • Gannan Tibetan Autonomous Prefecture People's Hospital
      • Contact: Yonggang Lv, MD; Phone Number: 86-13512224465; Email: liyizelisa@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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.	Other: plain areas; Patients should be long staying residents in plain areas (altitude level below 1,000 meters above sea level); Drug: Remifentanil Hydrochloride; Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia; Other Names: Remifentanil
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	48 hours after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 30, 2021
• Primary Completion (Anticipated): December 15, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: August 21, 2021
• First Submitted That Met QC Criteria: August 28, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 28, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Remifentanil; pain intensity; Postoperative pain; Opioid-induced hyperalgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Sensation Disorders; Somatosensory Disorders; Pain, Postoperative; Hyperalgesia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Remifentanil; Sufentanil; Dsuvia
• Other Study ID Numbers: GWang014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No