NCT02813044

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

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 16, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

June 22, 2016

Last Update Submit

September 28, 2020

Conditions

Pituitary Tumor

Keywords

anesthesiaintravenousneurosurgerypituitary neoplasmpostoperative period

Outcome Measures

Primary Outcomes (1)

  • QoR-40 score

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

    1 day

Study Arms (2)

TIVA group

EXPERIMENTAL

Anesthesia is maintained with propofol during surgery

Drug: total intravenous anesthesia (TIVA)

inhalation anesthesia group

ACTIVE COMPARATOR

Anesthesia is maintained with sevoflurane during surgery

Drug: inhalation anesthesia group

Interventions

total intravenous anesthesia (TIVA)DRUG

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

TIVA group
inhalation anesthesia groupDRUG

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.

inhalation anesthesia group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Associate Professor Department of Anesthesiology and Pain Medicine,

Seoul, 120-752, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 15710025BACKGROUND

MeSH Terms

Conditions

Pituitary Neoplasms

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 24, 2016

Study Start

June 16, 2016

Primary Completion

June 15, 2018

Study Completion

June 15, 2018

Last Updated

September 29, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)