Effect of ANI on Intraoperative Opioid Consumption | NCT05106452

Studies
Effect of ANI on Intraoperative Opioid Consumption

NCT05106452

Sponsor

Zonguldak Bulent Ecevit University

Status

Unknown status

Last Update Posted

Nov 11, 2021Actual

Enrollment

35Estimated

Phase

Not provided

Conditions

Analgesia
Nociceptive Pain
Nerve Block
Pain

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2021Actual

Primary Completion Date

Feb 28, 2023Estimated

Completion Date

May 1, 2023Estimated

First Submitted Date

Oct 22, 2021

First Submission Date that Met QC Criteria

Oct 22, 2021

First Posted Date

Nov 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2021

Last Update Posted Date

Nov 11, 2021Actual

Name	Class
Zeynep Koc	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to compare the analgesic nociception index (ANI), which is used to determine the dose of analgesic agent needed in the intraoperative period, with the conventional method in patients with erector spinae block who underwent gynecological surgery under general anesthesia.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intraoperative opioid consumption	Effect of ANI monitoring on intraoperative opioid consumption	during the surgery

Secondary Outcomes

Measure	Description	Time Frame
emergence time	time between last suture and extubation	at the end of the surgery
VAS pain scores	pain scores in the recovery unit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I-II-III risk group
Patients who underwent gynecological surgery under general anesthesia, who underwent erector spina block, and whose pain was followed by analgesia nociception index or conventional methods for intraoperative pain monitoring
Patients whose informed consent was read and consent was obtained from them and their guardians

Exclusion Criteria:

cardiac rhythm disorder
central-autonomic nervous system disease
neuropsychiatric disease
receiving opioid therapy
Use of drugs that will affect cardiac autonomic regulation
Known allergy to the drugs to be applied
Contraindicated for ESP block
Patients who do not agree to participate in the study will not be included in the study.
Patients who were administered drugs to stabilize the patient's hemodynamics during the operation

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

female patients gynecological surgery under general anesthesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
çağdaş baytar, MD	Contact	+905542255960		cagdasbaytar31@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zonguldak Bülent Ecevit University Medicine Faculty	Recruiting	Zonguldak	Kozlu	67600	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40663304	Derived	Koc Z, Baytar C, Bollucuoglu K, Koksal BG, Okyay RD, Piskin O, Ayoglu H. Intraoperative analgesia management by monitoring the analgesia nociception index in gynecological surgeries involving erector spinae plane block: a randomized controlled study. J Clin Monit Comput. 2025 Dec;39(6):1185-1191. doi: 10.1007/s10877-025-01330-x. Epub 2025 Jul 15.

Label	Type	Description	Intervention Names
Group ANI
Group Control

ID	Term
D000377	Agnosia
D059226	Nociceptive Pain
D010146	Pain

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases