Effect of Daytime Variation on Postoperative Hyperalgesia Induced by Opioids

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05234697
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Actual Duration (Months): 4.2
• Patients Per Site Per Month: 14.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Hyperalgesia	Drug: Remifentanil

Study Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effect of Daytime Variation on Postoperative Hyperalgesia Induced by Opioids
• Actual Study Start Date: Jan 12, 2022
• Actual Primary Completion Date: May 20, 2022
• Actual Study Completion Date: May 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Morning group Surgery performed during 08:00 to 12:00	Drug: Remifentanil; Remifentanil was used for maintenance of anesthesia.
Afternoon group Surgery performed during 14:00 to 18:00	Drug: Remifentanil; Remifentanil was used for maintenance of anesthesia.

Outcome Measures

Primary Outcome Measures

1. Postoperative hyperalgesia when discharged from postanesthesia care unit [from the 30 minutes before the surgery until to the time when discharged from postanesthesia care unit]

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

Secondary Outcome Measures

1. Postoperative hyperalgesia at 24 hours after surgery [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 [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 [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 [from 30 minutes before the surgery until to 6 minutes after stop infusion of remifentanil]

   Determined by Elisa test

5. Activity of plasma nonspecific esterase [from 30 minutes before the surgery until to before anesthesia induction]

   Determined by laboratory detection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University	Chongqing	Chongqing	China	400010

Sponsors and Collaborators

• The Second Affiliated Hospital of Chongqing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Second Affiliated Hospital of Chongqing Medical University
• ClinicalTrials.gov Identifier: NCT05234697
• Other Study ID Numbers: Postoperative hyperalgesia
• First Posted: Feb 10, 2022
• Last Update Posted: May 25, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Hyperalgesia; Remifentanil

Study Results

No Results Posted as of May 25, 2022