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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05028049
• Other study ID #: GWang014
• Status: Not yet recruiting
• Start date: August 30, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2021
• Source: Tianjin Medical University General Hospital
• Contact: Guolin Wang, MD
• Phone: +8618604755166
• Email: wangguolinghad[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 31, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anesthesia
• Hyperalgesia
• Pain, Postoperative

Intervention

Drug:
• Sufentanil injection
Sufentanil 0.3 µg/kg is intravenously administrated to maintain intraoperative analgesia
• Remifentanil Hydrochloride
Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia

Other:
• plain areas
Patients should be long staying residents in plain areas (altitude level below 1,000 meters above sea level)
• plateau areas
Patients should be long staying residents in plateau areas (altitude level>3000 meters above sea level)

Locations

Country	Name	City	State
China	Gannan Tibetan Autonomous Prefecture People's Hospital	Hezuo	Gansu
China	Tianjin Medical University General Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

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