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Effects of Total Intravenous Anesthesia With Propofol-remifentanil Versus Inhalational Anesthesia With Sevoflurane on Quality of Recovery in Patients Undergoing Transsphenoidal Surgery for Pituitary Tumor

Primary Purpose

Pituitary Tumor

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

total intravenous anesthesia (TIVA)

inhalation anesthesia group

About this trial

This is an interventional other trial for Pituitary Tumor focused on measuring anesthesia, intravenous, neurosurgery, pituitary neoplasm, postoperative period

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients over age 19
Scheduled to undergo transsphenoidal surgery for pituitary tumor
ASA class I and II

Exclusion Criteria:

Left ventricular ejection fraction < 55%
Third-degree atrioventricular block
Second-degree atrioventricular block (P:QRS ratio of 3:1 or higher)
Fever
History of myocardial infarction, stroke or cardiac surgery within the previous 1 year
Severe neurological disease
Use of sedative, opioid or sleep-inducing drugs
Allergic history of any study drug
Pregnancy

Sites / Locations

Associate Professor Department of Anesthesiology and Pain Medicine,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TIVA group

inhalation anesthesia group

Arm Description

Anesthesia is maintained with propofol during surgery

Anesthesia is maintained with sevoflurane during surgery

Outcomes

Primary Outcome Measures

QoR-40 score

We compare the QoR-40 scores of two groups 1 day after the operation.

Secondary Outcome Measures

Full Information

NCT ID

NCT02813044

First Posted

June 22, 2016

Last Updated

September 28, 2020

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02813044

Brief Title

Effects of Total Intravenous Anesthesia With Propofol-remifentanil Versus Inhalational Anesthesia With Sevoflurane on Quality of Recovery in Patients Undergoing Transsphenoidal Surgery for Pituitary Tumor

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

June 16, 2016 (Actual)

Primary Completion Date

June 15, 2018 (Actual)

Study Completion Date

June 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A number of studies have compared the effects of total intravenous anesthesia(TIVA) versus inhalational anesthesia on perioperative period during transsphenoidal surgery. However, they have limitations especially for the phase of recovery after anesthesia: a fragmentary assessment. Quality of Recovery 40 (QoR-40) questionnaire was multi-dimensionally designed to assess the degree of recovery, specially after anesthesia and surgery. In this study, the investigators aim to compare the quality of recovery after inhalational anesthesia and after TIVA through QoR-40 questionnaire in patients undergoing transsphenoidal surgery for pituitary tumor under general anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pituitary Tumor

Keywords

anesthesia, intravenous, neurosurgery, pituitary neoplasm, postoperative period

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TIVA group

Arm Type

Experimental

Arm Description

Anesthesia is maintained with propofol during surgery

Arm Title

inhalation anesthesia group

Arm Type

Active Comparator

Arm Description

Anesthesia is maintained with sevoflurane during surgery

Intervention Type

Drug

Intervention Name(s)

total intravenous anesthesia (TIVA)

Intervention Description

In the TIVA group,anesthesia is induced and maintained by effect-site target controlled infusion of propofol and remifentanil.

Intervention Type

Drug

Intervention Name(s)

inhalation anesthesia group

Intervention Description

In the inhalation anesthesia group, anesthesia is induced by pentothal sodium 4-6mg/kg and remifentanil 1 μg/kg, and then maintained with end-tidal sevoflurane concentration of 0.8 to 1 MAC and continuous infusion of remifentanil at 0.1-0.3μg/kg/min.

Primary Outcome Measure Information:

Title

QoR-40 score

Description

We compare the QoR-40 scores of two groups 1 day after the operation.

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients over age 19 Scheduled to undergo transsphenoidal surgery for pituitary tumor ASA class I and II Exclusion Criteria: Left ventricular ejection fraction < 55% Third-degree atrioventricular block Second-degree atrioventricular block (P:QRS ratio of 3:1 or higher) Fever History of myocardial infarction, stroke or cardiac surgery within the previous 1 year Severe neurological disease Use of sedative, opioid or sleep-inducing drugs Allergic history of any study drug Pregnancy

Facility Information:

Facility Name

Associate Professor Department of Anesthesiology and Pain Medicine,

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

15710025

Citation

Al-Shaikh B, George William M, Van Zundert AA. Using atmospheric pressure to inflate the cuff of the Portex Laryngeal Mask. Anaesthesia. 2005 Mar;60(3):296-7. doi: 10.1111/j.1365-2044.2005.04135.x. No abstract available.

Results Reference

background

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