Effect of ANI on Intraoperative Opioid Consumption

Sponsor

Zonguldak Bulent Ecevit University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05106452

Collaborator

Zeynep Koc (Other)

Enrollment

Location

18.3

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia Nociceptive Pain Nerve Block Pain

Study Design

Study Type:

Observational

Anticipated Enrollment :

35 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Intraoperative Analgesia Management in Gynecological Surgery With Erector Spinae Block

Actual Study Start Date :

Oct 20, 2021

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Group ANI
Group Control

Outcome Measures

Primary Outcome Measures

intraoperative opioid consumption [during the surgery]
Effect of ANI monitoring on intraoperative opioid consumption

Secondary Outcome Measures

emergence time [at the end of the surgery]
time between last suture and extubation
VAS pain scores [during her stay in the recovery unit]
pain scores in the recovery unit
duration of stay in recovery room [at the end of the surgery]
time between entering and exiting the recovery unit
nausea and vomiting i [during her stay in the recovery unit]
incidence of nausea and vomiting in recovery room

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zonguldak Bülent Ecevit University Medicine Faculty	Zonguldak	Kozlu	Turkey	67600

Sponsors and Collaborators

Zonguldak Bulent Ecevit University
Zeynep Koc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Çağdaş Baytar, assistant professor, Zonguldak Bulent Ecevit University

ClinicalTrials.gov Identifier:

NCT05106452

Other Study ID Numbers:

2021/18-4

First Posted:

Nov 3, 2021

Last Update Posted:

Nov 11, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Çağdaş Baytar, assistant professor, Zonguldak Bulent Ecevit University

Analgesia nociception index

Pain monitoring

Analgesia

Additional relevant MeSH terms:

Nociceptive Pain

Study Results

No Results Posted as of Nov 11, 2021