The Effect of Anaesthesia Depth on Oculo-cardiac Reflex

NCT02379546 | Completed Phase 4 DMC

• 1 other identifier: GaziosmanpashaU-2
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Strabismus; Anesthesia, General

Keywords

reflex, oculocardiac; monitoring, intraoperative

Outcome Measures

Primary Outcomes (1)

• The effect of the anaesthesia depth on the incidence of oculocardiac reflex

  during the traction of the extra-ocular muscle in the strabismus surgery

Secondary Outcomes (1)

• The incidence of the oculocardiac reflex depending the type of operated extra-ocular muscle during the strabismus surgery

  during the traction of the extra-ocular muscle in the strabismus surgery

Study Arms (2)

BIS<50

EXPERIMENTAL

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.

Drug: Desflurane; Device: Bispectral index monitoring

BIS≥50

ACTIVE COMPARATOR

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.

Drug: Desflurane; Device: Bispectral index monitoring

Interventions

Desflurane DRUG

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

BIS<50; BIS≥50

Bispectral index monitoring 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

Also known as: BIS

BIS<50; BIS≥50

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• have a neurological or cardiovascular disease
• receiving antiepileptic or another medications known to affect EEG or ECG

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tuğba Karaman

Tokat Province, Merkez, 60100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Strabismus

Interventions

Desflurane

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Tuğba Karaman

  GOU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: February 17, 2015
• First Posted: March 5, 2015
• Study Start: August 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

TU (1)