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

Pituitary Tumor Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813044
• Other study ID #: 4-2016-0344
• Status: Completed
• Phase: N/A
• Start date: June 16, 2016
• Est. completion date: June 15, 2018

Study information

• Verified date: September 2020
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor

Intervention

Drug:
• total intravenous anesthesia (TIVA)
In the TIVA group,anesthesia is induced and maintained by effect-site target controlled infusion of propofol and remifentanil.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Associate Professor Department of Anesthesiology and Pain Medicine,	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QoR-40 score	We compare the QoR-40 scores of two groups 1 day after the operation.	1 day