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Completed

NCT Number: NCT05234697

Effect of Daytime Variation on Postoperative Hyperalgesia Induced by Opioids

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.

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Key information

Conditions

Postoperative Hyperalgesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Chongqing, Chongqing Municipality, 400010, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Remifentanil

Drug

Remifentanil was used for maintenance of anesthesia.

Primary outcomes

  1. Postoperative hyperalgesia when discharged from postanesthesia care unit

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

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

Secondary outcomes

  1. Postoperative hyperalgesia at 24 hours after surgery

    Time frame: from the 30 minutes before the surgery until to 24 hours after surgery

    The ratio of pressure pain threshold at 24 hours after surgery compare to before surgery

  2. Postoperative pain intensity

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

    Pain intensity was assessed by numerical rating scale (0-10, 0 represents painless; 10 represents intolerable pain)

  3. Postoperative analgesic requirements

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

    Analgesic requirements was assessed by recording the volume of patient controlled analgesia pump

  4. Plasma concentration of remifentanil and sufentanil

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

    Determined by Elisa test

  5. Activity of plasma nonspecific esterase

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

    Determined by laboratory detection

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Chongqing Medical University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2022
Registry last updated
Dec 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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