Comparison of Volatile Anesthetics on Cerebral Oxygenation During Controlled Hypotension

• Sponsor: Ufuk University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02834845
• Collaborator: (none)
• Enrollment: 95
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 47.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oxygen Saturation	Drug: Sevoflurane; Drug: Desflurane	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Comparison of Effects of Sevoflurane and Desflurane on Cerebral Oxygenation During Controlled Hypotension
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sevoflurane	Drug: Sevoflurane; Sevoflurane %2-3 for general anesthesia maintenance
Experimental: Desflurane	Drug: Desflurane; Desflurane %6-8 for general anesthesia maintenance

Outcome Measures

Primary Outcome Measures

1. Cerebral oxygen saturation as measured by Near Infrared Spectroscopy [Duration of surgery]

   The effect of sevoflurane and desflurane on NIRS values

Secondary Outcome Measures

1. Total remifentanil consumption as measured in micrograms [Duration of surgery]

2. The effect of anesthetics on hemodynamic variables [Duration of surgery]

   The effects of sevoflurane and desflurane on mean arterial pressure

3. The effect of anesthetics on hemodynamic variables [Duration of surgery]

   The effects of sevoflurane and desflurane on heart rate

4. The effect of anesthetics on hemodynamic variables [Duration of surgery]

   The effects of sevoflurane and desflurane on bispectral index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients in American Society of Anesthesiology (ASA) classification I and II

• Patients undergoing elective septoplasty operation

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ufuk University Hospital	Ankara		Turkey

Sponsors and Collaborators

• Ufuk University

Investigators

• Principal Investigator: Ülkü C Köksoy, MD, Fellow

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Perihan Ekmekçi, Associate Professor, Ufuk University
• ClinicalTrials.gov Identifier: NCT02834845
• Other Study ID Numbers: 2016Sept
• First Posted: Jul 15, 2016
• Last Update Posted: Aug 19, 2020
• Last Verified: Aug 1, 2020

• Additional relevant MeSH terms: Hypotension; Sevoflurane; Desflurane

Study Results

No Results Posted as of Aug 19, 2020