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ANI-guided Intraoperative Analgesia vs Conventional Intraoperative Analgesia

Primary Purpose

Postoperative Pain, Analgesia, Surgery

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

ANI-guided intraoperative analgesia

Conventional intraoperative analgesia

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18
Elective open gynecological surgery
American Society of Anaesthesiologists physical status classification 1-3

Exclusion Criteria:

Laparoscopic surgery or robot-assisted surgery
Patients who had analgesic agents, anti-psychotic agents, anticonvulsants which were related to chronic pain
Patients who had hypersensitivity to analgesic agents or medications related anesthesia.
Patients who were required to have mechanical ventilation after surgery
Patients who had arrhythmia
Patients who transferred to the surgical intensive care unit immediately after surgery
Pregnancy

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ANI-guided intraoperative analgesia

Conventional intraoperative analgesia

Arm Description

Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI index.

Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil at the discretion of attending anesthesiologists based on hemodynamic parameters.

Outcomes

Primary Outcome Measures

the incidence of moderate-to-severe postoperative pain

the incidence of moderate-to-severe postoperative pain is defined as a case in which pain with numeric rating scale (NRS) of 5 or more is reported during stays in the postanesthesia care unit. Pain assessment is performed two times during stays in the postanesthesia care unit.

Secondary Outcome Measures

the amount of intraoperative remifentanil

the amount of intraoperative remifentanil used during anesthesia

Quality of Recovery-15 (QoR-15) score

QoR-15 questionnaire is recorded by an investigator. QoR-15 questionnaire has minimum score of 0 and maximum score of 150, and higher score indicates the better quality of recovery.

the incidence of postoperative nausea and vomiting

the incidence of postoperative nausea and vomiting is recorded by an investigator

11-pointed NRS pain score

11-pointed NRS pain score is measured at both resting state and movement. 11-pointed NRS pain score has minimum score of 0 and maximum score of 10, and higher score indicates the higher severity of pain.

Full Information

NCT ID

NCT04877574

First Posted

April 30, 2021

Last Updated

September 15, 2022

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04877574

Brief Title

ANI-guided Intraoperative Analgesia vs Conventional Intraoperative Analgesia

Official Title

Effects of Analgesia Nociception Index (ANI)-Guided Intraoperative Analgesia on Postoperative Pain: a Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

July 1, 2021 (Actual)

Primary Completion Date

July 11, 2022 (Actual)

Study Completion Date

July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study evaluates the effects of Analgesia Nociception Index (ANI)-guided intraoperative analgesia on postoperative pain in patients undergoing open gynecologic surgery.

Detailed Description

Postoperative pain is one of the most common postoperative complications and is significantly associated with patient's quality of recovery. Analgesia Nociception Index (ANI) is known to analyze the high frequency component of heart rate variability in relation to respiratory frequency, providing the objective information on the degree of pain. However, most previous studies conducted by using ANI were observational studies or small-sized randomized controlled studies. In the present study, the investigators aimed to evaluate the effects of ANI-guided intraoperative analgesia on moderate-to-severe postoperative pain by performing randomized controlled study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Analgesia, Surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

170 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ANI-guided intraoperative analgesia

Arm Type

Experimental

Arm Description

Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI index.

Arm Title

Conventional intraoperative analgesia

Arm Type

Active Comparator

Arm Description

Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil at the discretion of attending anesthesiologists based on hemodynamic parameters.

Intervention Type

Procedure

Intervention Name(s)

ANI-guided intraoperative analgesia

Intervention Description

Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI.

Intervention Type

Procedure

Intervention Name(s)

Conventional intraoperative analgesia

Intervention Description

Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil at the discretion of attending anesthesiologists based on hemodynamic parameters.

Primary Outcome Measure Information:

Title

the incidence of moderate-to-severe postoperative pain

Description

Time Frame

during 1 hour of stay in the postanesthesia care unit

Secondary Outcome Measure Information:

Title

the amount of intraoperative remifentanil

Description

the amount of intraoperative remifentanil used during anesthesia

Time Frame

intraoperative

Title

Quality of Recovery-15 (QoR-15) score

Description

QoR-15 questionnaire is recorded by an investigator. QoR-15 questionnaire has minimum score of 0 and maximum score of 150, and higher score indicates the better quality of recovery.

Time Frame

at postoperative 24 hour

Title

the incidence of postoperative nausea and vomiting

Description

the incidence of postoperative nausea and vomiting is recorded by an investigator

Time Frame

at postoperative 1 hour, 24 hour, 72 hour

Title

11-pointed NRS pain score

Description

Time Frame

at postoperative 24 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 Elective open gynecological surgery American Society of Anaesthesiologists physical status classification 1-3 Exclusion Criteria: Laparoscopic surgery or robot-assisted surgery Patients who had analgesic agents, anti-psychotic agents, anticonvulsants which were related to chronic pain Patients who had hypersensitivity to analgesic agents or medications related anesthesia. Patients who were required to have mechanical ventilation after surgery Patients who had arrhythmia Patients who transferred to the surgical intensive care unit immediately after surgery Pregnancy

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

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ANI-guided Intraoperative Analgesia vs Conventional Intraoperative Analgesia

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