A Prospective, Randomized Controlled Study to Compare the Effect of Sevoflurane and Propofol for Maintenance of Anesthesia on Postoperative Recovery After Transsphenoidal Resection of Pituitary Adenoma

Peking Union Medical College Hospital1 site in 1 country252 target enrollmentMay 3, 2023

ConditionsPituitary Adenoma

Interventionssevoflurane propofol

Drugssevoflurane propofol

Overview

Phase: Phase 4
Intervention: sevoflurane
Conditions: Pituitary Adenoma
Sponsor: Peking Union Medical College Hospital
Enrollment: 252
Locations: 1
Primary Endpoint: 15-item quality of recovery score (QoR-15)
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Currently, total intravenous anesthesia (TIVA) and inhaled anesthesia are both commonly used for transsphenoidal pituitary adenoma resection. However, optimal choice for anesthesia maintenance in transsphenoidal surgery remains unclear. Previous studies focusing on this question provided fragmentary assessment and controversial results. The goal of this clinical trial is to investigate whether propofol and sevoflurane have different effect on post-anesthetic recovery after transsphenoidal resection of pituitary adenoma.

Registry

clinicaltrials.gov

Start Date

May 3, 2023

End Date

August 14, 2024

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peking Union Medical College Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men or women, aged from 18 to 70
•American Society of Anesthesiologists (ASA) class I - III
•Patients scheduled for transsphenoidal surgery requiring general anesthesia managed with endotracheal intubation

Exclusion Criteria

•Patients allergic or contraindicated to sevoflurane, propofol, or other drugs used during surgery
•Severe pulmonary disease, saturation of peripheral oxygen (SpO2) \< 90%
•Severe nervous system disease with consciousness disorder
•Patients scheduled for intensive care unit (ICU) after surgery

Arms & Interventions

sevoflurane

Anesthesia is maintained with sevoflurane.

Intervention: sevoflurane

propofol

Anesthesia is maintained with continuous infusion of propofol.

Intervention: propofol

Outcomes

Primary Outcomes

15-item quality of recovery score (QoR-15)

Time Frame: 24 hours after end of surgery

The QoR-15 score ranges from 0 to 150 (higher is better). The investigators record the scores of two groups 1 day after the surgery.

Secondary Outcomes

Time to awake from anesthesia(From stopping sevoflurane or propofol to awake, approximately 30 minutes)
Time to extubation(From stopping sevoflurane or propofol to recovery of spontaneous breathing and withdrawal of tracheal tube, approximately 30 minutes)
Coughing and bucking during emergence(From stopping sevoflurane or propofol to complete awakening, approximately 30 minutes)
Time to discharge from postanesthesia care unit (PACU)(From admit into PACU to discharge from PACU, approximately 45 minutes)
Concentration of serum growth hormone (GH)(24 hours after end of surgery)
Incidence of hypotension during anesthesia(From start of surgery to end of surgery, on an average of 2 hours)
Concentration of serum thyroid-stimulating hormone (TSH)(24 hours after end of surgery)
Concentration of serum prolactin (PRL)(24 hours after end of surgery)
Counts of peripheral blood lymphocyte(24 hours after end of surgery)
Agitation or sedation level during emergence(From stopping sevoflurane or propofol to complete awakening, approximately 30 minutes)
PACU antiemetic drug use(From admit into PACU to discharge from PACU, approximately 45 minutes)
PACU analgesic drug use(From admit into PACU to discharge from PACU, approximately 45 minutes)
Post operative nausea and vomiting score(24 hours after end of surgery)
Concentration of serum adrenocorticotropic hormone (ACTH)(24 hours after end of surgery)
Concentration of serum cortisol(24 hours after end of surgery)
Concentration of serum gonadotrophin(24 hours after end of surgery)
Incidence of hypertension during anesthesia(From start of surgery to end of surgery, on an average of 2 hours)
Time to discharge from hospital(From end of surgery to discharge from hospital, on an average of 2 days)