Effect of ANI on Intraoperative Opioid Consumption

NCT05106452 | Unknown

• 1 other identifier: 2021/18-4
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Nociceptive Pain; Nerve Block; Pain

Keywords

Analgesia nociception index; Pain monitoring; Analgesia

Outcome Measures

Primary Outcomes (1)

• intraoperative opioid consumption

  Effect of ANI monitoring on intraoperative opioid consumption

  during the surgery

Secondary Outcomes (4)

• emergence time

  at the end of the surgery

• VAS pain scores

  during her stay in the recovery unit

• duration of stay in recovery room

  at the end of the surgery

• nausea and vomiting i

  during her stay in the recovery unit

Study Arms (2)

Group ANI

Group Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

female patients gynecological surgery under general anesthesia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead
• Zeynep Koc: collaborator

Study Sites (1)

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• 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.

  PMID: 40663304 DERIVED

MeSH Terms

Conditions

Agnosia; Nociceptive Pain; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

çağdaş baytar, MD

CONTACT

+905542255960; cagdasbaytar31@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 3, 2021
• Study Start: October 20, 2021
• Primary Completion: February 28, 2023
• Study Completion: May 1, 2023
• Last Updated: November 11, 2021

Record last verified: 2021-11

Locations

TU (1)