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

NCT ID: NCT02813044

Last Updated: 2020-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-16

Study Completion Date

2018-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Pituitary Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TIVA group

Anesthesia is maintained with propofol during surgery

Group Type EXPERIMENTAL

total intravenous anesthesia (TIVA)

Intervention Type DRUG

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

inhalation anesthesia group

Anesthesia is maintained with sevoflurane during surgery

Group Type ACTIVE_COMPARATOR

inhalation anesthesia group

Intervention Type DRUG

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.

Interventions

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total intravenous anesthesia (TIVA)

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

Intervention Type DRUG

inhalation anesthesia group

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Associate Professor Department of Anesthesiology and Pain Medicine,

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 15710025 (View on PubMed)

Other Identifiers

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4-2016-0344

Identifier Type: -

Identifier Source: org_study_id

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