The Effect of Anaesthesia Depth on Oculo-cardiac Reflex

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was designed to determine the effect of the depth of anesthesia on the oculocardiac reflex (OCR) during pediatric strabismus surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Relation Between Oculocardiac Reflex and Laryngospasm

NCT05339880

Eye Abnormalities Arrythmia

UNKNOWN

Evaluation of Perioperative Anesthesia Requirements of Outpatient Cataract Patients

NCT06824935

Preoperative Evaluation Outpatient Cataract Surgery Anesthesia

ENROLLING_BY_INVITATION

Neuro-Mimic Indicators of Anesthesia Depth During General Anesthesia

NCT07199049

General Anesthesia Intraoperative Awareness Eye Movements

NOT_YET_RECRUITING

Effects of Different Types of Anaesthesia on Intraocular Pressure During Lumbar Disc Herniation Surgery

NCT06070480

Anesthesia Disk Herniated Lumbar Intraocular Pressure

COMPLETED NA

Low-Flow Desflurane Anesthesia and Its Effects on BIS and Postoperative Cognitive Functions

NCT07212543

Major Abdominal Surgeries

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The oculo-cardiac reflex (OCR) is a trigeminovagal reflex which is started by the stimulus on the extra-ocular muscle and may lead to serious bradycardia or arrhythmia in the patients during strabismus surgery. It is presumed that the depth of anesthesia is one of the influencing factor on the OCR. But the clinical trials which are evaluating the relationship between the anesthesia depth and OCR are scarce. The main objective of this study is to determine the impact of the depth of anaesthesia that is adjusted with the bispectral index (BIS) monitor on the incidence of OCR in pediatric patients undergoing strabismus surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Strabismus Anesthesia, General

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BIS<50

Anaesthesia will be maintained with desflurane in a 50% O2-Air mixture by titrating the concentration according to the Bispectral index monitoring to keep the Bispectral index values below 50.

Group Type EXPERIMENTAL

Desflurane

Intervention Type DRUG

Desflurane will be used to maintain the anesthesia and the dose of desflurane will be adjusted according to the Bispectral İndex Monitoring

Bispectral index monitoring

Intervention Type DEVICE

Bispectral index monitoring (BIS XP, A-2000, VERSİON 3.31, Aspect Medical Systems, Newton, Mass, USA)will be used to determine the depth of anesthesia

BIS≥50

Anaesthesia will be maintained with desflurane in a 50% O2-Air mixture by titrating the concentration according to the Bispectral index monitoring to keep the Bispectral index values above 50.

Group Type ACTIVE_COMPARATOR

Desflurane

Intervention Type DRUG

Desflurane will be used to maintain the anesthesia and the dose of desflurane will be adjusted according to the Bispectral İndex Monitoring

Bispectral index monitoring

Intervention Type DEVICE

Bispectral index monitoring (BIS XP, A-2000, VERSİON 3.31, Aspect Medical Systems, Newton, Mass, USA)will be used to determine the depth of anesthesia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Desflurane

Desflurane will be used to maintain the anesthesia and the dose of desflurane will be adjusted according to the Bispectral İndex Monitoring

Intervention Type DRUG

Bispectral index monitoring

Bispectral index monitoring (BIS XP, A-2000, VERSİON 3.31, Aspect Medical Systems, Newton, Mass, USA)will be used to determine the depth of anesthesia

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BIS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* physical status ASA (American Society of Anesthesiologists) I
* scheduled for elective strabismus surgery under general anesthesia
* aged between 3-16 years