Comparison of Postoperative Recovery of Sevoflurane and Propofol After Transsphenoidal Surgery

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05822817
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Peking Union Medical College Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yuguang Huang, MDLulu Ma, MDBing Xing, MDWei Lian, MD
Principal Investigator Affiliation	Department of Anesthesiology, Peking Union Medical College HospitalDepartment of Anesthesiology, Peking Union Medical College HospitalDepartment of Neurosurgery, Peking Union Medical College HospitalDepartment of Neurosurgery, Peking Union Medical College Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pituitary Adenoma

Arms & Interventions

Arms

Experimental: sevoflurane

Anesthesia is maintained with sevoflurane.

Experimental: propofol

Anesthesia is maintained with continuous infusion of propofol.

Interventions

Drug: - sevoflurane

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.

Drug: - propofol

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.

Contact a Trial Team

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International Sites

Peking Union Medical College Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking Union Medical College Hospital

Beijing, Beijing, 100730

Site Contact

Lulu Ma, MD

[email protected]

13811049619

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