Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02813044
Other study ID # 4-2016-0344
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04529356 - The TMS Treatment for Postoperative Headache in GH Tumor N/A
Completed NCT03363126 - Visual Outcome After Transsphenoidal Surgery for Pituitary Macroadenoma N/A
Completed NCT04212793 - Detection of PitNET Tissue During TSS Using Bevacizumab-800CW Phase 1
Recruiting NCT03309319 - A Pilot Study of Rosiglitazone in the Treatment of GH Secreting Pituitary Adenomas N/A
Terminated NCT04106531 - Validation of a Quality of Life Metric "Prolac-10"
Recruiting NCT03719781 - Postoperative Cognitive Dysfunction in Patients Undergoing Pituitary Removal Surgery
Recruiting NCT01556230 - Prospective Study of Clinically Nonfunctioning Pituitary Adenomas
Recruiting NCT03132259 - Comparative Low and High Dose of Dexmedethomidine in Pituitary Tumor Removal by Transphenoid Approach Phase 4
Recruiting NCT01368133 - The Observational Study of Growth Hormone-secreting Pituitary Tumors N/A
Withdrawn NCT04863339 - Tranexamic Acid for Blood Loss Minimization in Endoscopic Pituitary Surgery Phase 2
Terminated NCT00646308 - Assessment of Cardiovascular Risk Markers in Growth Hormone Deficient Patients With Nonsecreting Pituitary Adenomas N/A
Recruiting NCT00852501 - Characterization of Receptors in Non-functioning Pituitary Macroadenomas Phase 4
Completed NCT03465423 - Comparison of Propofol Requirement Between Patients With Pituitary Somatotroph Tumor and With Nonfunctioning Pituitary Tumor in Transsphenoidal Pituitary Surgery Under Total Intravenous Anesthesia
Recruiting NCT03474601 - Seoul National University Pituitary Disease Cohort Study
Recruiting NCT05139277 - Evaluation of the CONVIVO System N/A
Active, not recruiting NCT03636568 - Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery) N/A
Recruiting NCT03973450 - Epidemiology of Pituitary Tumours: Prevalence of Associated Neoplasia
Active, not recruiting NCT04042753 - Nivolumab and Ipilimumab in People With Aggressive Pituitary Tumors Phase 2
Recruiting NCT04018963 - The Impact of Endoscopic Pituitary Surgery on Nasal Function
Not yet recruiting NCT04938401 - Construction and Application of a Risk Prediction Model Forepistaxis After Pituitary Tumor Resection