Comparison of Postoperative Recovery of Sevoflurane and Propofol After Transsphenoidal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-03

Study Completion Date

2024-08-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Pituitary Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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sevoflurane

Anesthesia is maintained with sevoflurane.

Group Type EXPERIMENTAL

sevoflurane

Intervention Type DRUG

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.

propofol

Anesthesia is maintained with continuous infusion of propofol.

Group Type EXPERIMENTAL

propofol

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No