NCT02709863

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

1.3 years

First QC Date

February 23, 2016

Last Update Submit

March 10, 2016

Conditions

Pituitary Adenoma

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Change from baseline FVC%predicted (no unit)

    Preoperative baseline, postoperative 1st hour and postoperative 24th hour

  • Change from baseline FEV1/FVC ratio (no units)

    Preoperative baseline, postoperative 1st hour and postoperative 24th hour

  • Change from baseline PaO2 (mmHg)

    Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour

  • Change from baseline PaCO2 (mmHg)

    Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour

  • Change from baseline pH

    Preoperative baseline, during the 1st hour of the operation, during the last hour of the operation, postoperative 1st hour and postoperative 24th hour

  • +4 more secondary outcomes

Study Arms (3)

Sevoflurane

ACTIVE COMPARATOR

1-1.5 minimum alveolar concentration (MAC), inhalation route, during operation

Drug: Sevoflurane

Desflurane

ACTIVE COMPARATOR

1-1.5 minimum alveolar concentration (MAC), inhalation route, during operation

Drug: Desflurane

Propofol

ACTIVE COMPARATOR

6-10 mg/kg/h, iv infusion, during operation

Drug: Propofol

Interventions

SevofluraneDRUG

1-1.5 MAC, inhalation route, during operation

Also known as: Sevorane
Sevoflurane
DesfluraneDRUG

1-1.5 MAC, inhalation route, during operation

Also known as: Suprane
Desflurane
PropofolDRUG

6-10 mg/kg/h, iv infusion, during operation

Propofol

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Significant cardiopulmonary disease,
  • Diagnosed obstructive or restrictive pulmonary disease,
  • Patients with chest wall deformities, liver or kidney failure,
  • Postoperative lack of cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa Medical Faculty Neurosurgery Department

Istanbul, 34098, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

SevofluraneDesfluranePropofol

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl EthersPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Özlem Korkmaz Dilmen, Assoc. Prof.

    Istanbul University

    STUDY DIRECTOR

Central Study Contacts

Abdulvahap Oguz, MD

CONTACT

00905444461924avahapoguz@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 23, 2016

First Posted

March 16, 2016

Study Start

October 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

March 16, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)