NCT02834845

Brief Summary

Controlled hypotension is a preferred method for reducing surgical bleeding during septoplasty operations however, the level of hypotension and bradycardia should not disrupt cerebral oxygenation. On this account, the investigators aim to investigate the effects of different volatile anesthetics combined with a short-acting opioid on cerebral oxygenation during controlled hypotension using near infrared spectroscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

2 months

First QC Date

June 24, 2016

Last Update Submit

August 18, 2020

Conditions

Oxygen Saturation

Outcome Measures

Primary Outcomes (1)

  • Cerebral oxygen saturation as measured by Near Infrared Spectroscopy

    The effect of sevoflurane and desflurane on NIRS values

    Duration of surgery

Secondary Outcomes (4)

  • Total remifentanil consumption as measured in micrograms

    Duration of surgery

  • The effect of anesthetics on hemodynamic variables

    Duration of surgery

  • The effect of anesthetics on hemodynamic variables

    Duration of surgery

  • The effect of anesthetics on hemodynamic variables

    Duration of surgery

Study Arms (2)

Sevoflurane

EXPERIMENTAL
Drug: Sevoflurane

Desflurane

EXPERIMENTAL
Drug: Desflurane

Interventions

SevofluraneDRUG

Sevoflurane %2-3 for general anesthesia maintenance

Sevoflurane
DesfluraneDRUG

Desflurane %6-8 for general anesthesia maintenance

Desflurane

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in American Society of Anesthesiology (ASA) classification I and II
  • Patients undergoing elective septoplasty operation

You may not qualify if:

  • Patients in ASA classification III and higher
  • Emergency surgery
  • Patients in New York Heart Association classification III-IV
  • Patients with known allergy to drugs used in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk University Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Interventions

SevofluraneDesflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Officials

  • Ülkü C Köksoy, MD

    Fellow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 24, 2016

First Posted

July 15, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 19, 2020

Record last verified: 2020-08

Locations

TU(1)