Effect of Daytime Variation on Postoperative Hyperalgesia Induced by Opioids

NCT05234697 | Completed DMC FDA Drug

• 1 other identifier: Postoperative hyperalgesia
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the effect of daytime variation on postoperative hyperalgesia induced by opioids. Patients receiving endoscopy surgery under general anesthesia during 08:00-12:00(morning group, n=30) and 14:00-18:00(afternoon group, n=30) using remifentanil for anesthesia maintenance were respectively included. Postoperative hyperalgesia at PACU and 24 hours after surgery were assessed through mechanical pain measurement. Comparative analysis of postoperative hyperalgesia levels, pain and analgesic requirements between morning group and afternoon group were performed.

Conditions

Postoperative Hyperalgesia

Outcome Measures

Primary Outcomes (1)

• Postoperative hyperalgesia when discharged from postanesthesia care unit

  The ratio of pressure pain threshold when discharged from PACU compare to before surgery

  from the 30 minutes before the surgery until to the time when discharged from postanesthesia care unit, assessed up to about 2 hours

Secondary Outcomes (5)

• Postoperative hyperalgesia at 24 hours after surgery

  from the 30 minutes before the surgery until to 24 hours after surgery

• Postoperative pain intensity

  from the time when the surgery was completed until to 24 hours after surgery

• Postoperative analgesic requirements

  from the time when the surgery was completed until to 24 hours after surgery

• Plasma concentration of remifentanil and sufentanil

  from 30 minutes before the surgery until to the time after stop infusion of remifentanil, assessed up to about 2 hours

• Activity of plasma nonspecific esterase

  from 30 minutes before the surgery until to the time after stop infusion of remifentanil, , assessed up to about 2 hours

Study Arms (2)

Morning group

Surgery performed during 08:00 to 12:00

Drug: Remifentanil

Afternoon group

Surgery performed during 14:00 to 18:00

Drug: Remifentanil

Interventions

Remifentanil DRUG

Remifentanil was used for maintenance of anesthesia.

Afternoon group; Morning group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving endoscopy surgery under general anesthesia during 08:00-12:00(morning group, n=30) and 14:00-18:00(afternoon group, n=30) using remifentanil for anesthesia maintenance were included.

You may qualify if:

• American Society of Anesthesiologists classification I-II
• Abdominal endoscopy surgery
• Estimated surgery duration 1-2h
• Right handedness
• Voluntarily receive postoperative intravenous controlled analgesia

You may not qualify if:

• Heavy smoking or alcohol dependence
• Puerpera or lactation women
• History of chronic pain
• Analgesic use within one month before surgery
• Allergy to opioids
• Can not follow with the study procedure

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Related Publications (1)

• Shu B, Liu H, Zheng X, He J, Wu Y, Chen J, Chen Y, Tian H, Ju D, Huang H, Duan G. Opioid infusions at different times of the day produce varying degrees of opioid-induced hyperalgesia. Br J Anaesth. 2023 Dec;131(6):1072-1081. doi: 10.1016/j.bja.2023.08.039. Epub 2023 Oct 9.

  PMID: 37821342 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood is collected before and after the surgery.

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 10, 2022
• Study Start: January 12, 2022
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)