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Trial Title:
Comparison of Postoperative Recovery of Sevoflurane and Propofol After Transsphenoidal Surgery
NCT ID:
NCT05822817
Condition:
Pituitary Adenoma
Conditions: Official terms:
Adenoma
Pituitary Neoplasms
Pituitary Diseases
Propofol
Sevoflurane
Conditions: Keywords:
Anesthesia
Transsphenoidal surgery
Enhanced recovery after surgery
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
sevoflurane
Description:
Anesthesia is maintained with inhalation of sevoflurane. The concentration of sevoflurane
was adjusted to maintain anesthetic depth, aiming for a bispectral index of 40-60.
Arm group label:
sevoflurane
Intervention type:
Drug
Intervention name:
propofol
Description:
Anesthesia is maintained with an effect-site target-controlled infusion of propofol
(2-6ug/ml) based on the Marsh mode. The concentration of propofol was adjusted to
maintain anesthetic depth, aiming for a bispectral index of 40-60.
Arm group label:
propofol
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Men or women, aged from 18 to 70
2. American Society of Anesthesiologists (ASA) class I - III
3. Patients scheduled for transsphenoidal surgery requiring general anesthesia managed
with endotracheal intubation
Exclusion Criteria:
1. Patients allergic or contraindicated to sevoflurane, propofol, or other drugs used
during surgery
2. Severe pulmonary disease, saturation of peripheral oxygen (SpO2) < 90%
3. Severe nervous system disease with consciousness disorder
4. Patients scheduled for intensive care unit (ICU) after surgery
5. Pregnancy
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Lulu Ma, MD
Phone:
13811049619
Email:
malulu@pumch.cn
Start date:
May 3, 2023
Completion date:
April 2024
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05822817
