Comparison of The Effects of Sevoflurane, Desflurane and Total Intravenous Anaesthesia on Pulmonary Function Tests

Pituitary Adenoma Clinical Trial

Official title:

Comparison of The Effects of Sevoflurane, Desflurane and Total Intravenous Anaesthesia on Pulmonary Function Tests in Patients Undergoing Endoscopic Endonasal Transsphenoidal Surgery of Pituitary Gland

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02709863
• Other study ID #: 83045809/604.01/02
• Status: Recruiting
• Phase: N/A
• First received: February 23, 2016
• Last updated: March 10, 2016
• Start date: October 2015
• Est. completion date: February 2017

Study information

• Verified date: March 2016
• Source: Istanbul University
• Contact: Abdulvahap Oguz, MD
• Phone: 00905444461924
• Email: avahapoguz[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study will compare the effects of sevoflurane, desflurane and total intravenous anaesthesia on pulmonary function tests in patients undergoing endoscopic endonasal transsphenoidal surgery of pituitary gland. Participants will be divided into three equal groups. The first group will receive sevoflurane, second grup will receive desflurane and third grup will receive total intravenous anaesthesia. Investigators are also going to evaluate blood gas analysis.

Description:

Investigators are going to evaluate forced expiratory volume in 1st Second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, partial pressure of arterial oxygen (PaO2), partial pressure of arterial carbon dioxide (PaCO2), potential of hydrogen (pH), arterial oxygen saturation (SaO2), base excess (BE), bicarbonate (HCO3) and partial pressure of arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio to compare the effects of drugs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) score I-II patients

Exclusion Criteria:

• Significant cardiopulmonary disease,

• Diagnosed obstructive or restrictive pulmonary disease,

• Patients with chest wall deformities, liver or kidney failure,

• Postoperative lack of cooperation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Pituitary Adenoma
• Pituitary Diseases

Intervention

Drug:
• Sevoflurane
1-1.5 MAC, inhalation route, during operation
• Desflurane
1-1.5 MAC, inhalation route, during operation
• Propofol
6-10 mg/kg/h, iv infusion, during operation

Locations

Country	Name	City	State
Turkey	Istanbul University Cerrahpasa Medical Faculty Neurosurgery Department	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline FEV1%predicted (no unit)	FEV1 is measured with spirolab III colour liquid-crystal-display medical spirometer. FEV1%predicted is calculated with age, sex, height and weight input by the same equipment.	Preoperative baseline, postoperative 1st hour and postoperative 24th hour	No
Secondary	Change from baseline FVC%predicted (no unit)	FVC is measured with spirolab III colour liquid-crystal-display medical spirometer. FVC%predicted is calculated with age, sex, height and weight input by the same equipment.	Preoperative baseline, postoperative 1st hour and postoperative 24th hour	No
Secondary	Change from baseline FEV1/FVC ratio (no units)	FEV1/FVC ratio is calculated by spirolab III colour liquid-crystal-display medical spirometer based on age, sex, height and weight.	Preoperative baseline, postoperative 1st hour and postoperative 24th hour	No
Secondary	Change from baseline PaO2 (mmHg)	PaO2 is a component of arterial blood gas analysis done with Cobas B221.	Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour	No
Secondary	Change from baseline PaCO2 (mmHg)	PaCO2 is a component of arterial blood gas analysis done with Cobas B221.	Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour	No
Secondary	Change from baseline pH	pH is a component of arterial blood gas analysis done with Cobas B221	Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour	No
Secondary	Change from baseline SaO2 (%)	SaO2 is a component of arterial blood gas analysis done with Cobas B221	Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour	No
Secondary	Change from baseline BE (mmol/L)	BE is a component of arterial blood gas analysis done with Cobas B221	Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour	No
Secondary	Change from baseline HCO3 (mmol/L)	HCO3 is a component of arterial blood gas analysis done with Cobas B221	Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour	No
Secondary	Change from baseline PaO2/FiO2 ratio (no units)	PaO2/FiO2 ratio is calculated by investigators	Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour	No