Comparison of Postoperative Recovery of Sevoflurane and Propofol After Transsphenoidal Surgery

NCT05822817 | Completed Phase 4

• 1 other identifier: K3501
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Adenoma

Keywords

Anesthesia; Transsphenoidal surgery; Enhanced recovery after surgery

Outcome Measures

Primary Outcomes (1)

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

  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.

  24 hours after end of surgery

Secondary Outcomes (18)

• 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

• Agitation or sedation level during emergence

  From stopping sevoflurane or propofol to complete awakening, 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

Other Outcomes (12)

• Number of participants with postoperative complications

  After the surgery till discharge

• Number of participants with postoperative complications

  After discharge till 7 days after the surgery

• Numerical rating scale (NRS) pain score at postoperative day 7

  7 days after the surgery

Study Arms (2)

sevoflurane

EXPERIMENTAL

Anesthesia is maintained with sevoflurane.

Drug: sevoflurane

propofol

EXPERIMENTAL

Anesthesia is maintained with continuous infusion of propofol.

Drug: propofol

Interventions

sevoflurane 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.

sevoflurane

propofol 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.

propofol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnancy

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (4)

• Cafiero T, Cavallo LM, Frangiosa A, Burrelli R, Gargiulo G, Cappabianca P, de Divitiis E. Clinical comparison of remifentanil-sevoflurane vs. remifentanil-propofol for endoscopic endonasal transphenoidal surgery. Eur J Anaesthesiol. 2007 May;24(5):441-6. doi: 10.1017/S0265021506002080. Epub 2007 Mar 12.

  PMID: 17376252 BACKGROUND

• Ali Z, Prabhakar H, Bithal PK, Dash HH. Bispectral index-guided administration of anesthesia for transsphenoidal resection of pituitary tumors: a comparison of 3 anesthetic techniques. J Neurosurg Anesthesiol. 2009 Jan;21(1):10-5. doi: 10.1097/ANA.0b013e3181855732.

  PMID: 19098618 BACKGROUND

• Kim DH, Min KT, Kim EH, Choi YS, Choi SH. Comparison of the effects of inhalational and total intravenous anesthesia on quality of recovery in patients undergoing endoscopic transsphenoidal pituitary surgery: a randomized controlled trial. Int J Med Sci. 2022 Jun 13;19(6):1056-1064. doi: 10.7150/ijms.72758. eCollection 2022.

  PMID: 35813289 BACKGROUND

• Feng Y, Zhang Y, Lian W, Xue Y, Ma M, Yu X, Guo X, Ma L, Xing B, Huang Y. A randomized controlled trial to compare the effects of sevoflurane and propofol for maintenance of anesthesia on postoperative recovery quality in patients undergoing transsphenoidal resection of pituitary adenoma. BMC Anesthesiol. 2025 Aug 4;25(1):392. doi: 10.1186/s12871-025-03263-z.

  PMID: 40760415 DERIVED

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Yuguang Huang, MD

  Department of Anesthesiology, Peking Union Medical College Hospital

  STUDY CHAIR

• Lulu Ma, MD

  Department of Anesthesiology, Peking Union Medical College Hospital

  STUDY DIRECTOR

• Bing Xing, MD

  Department of Neurosurgery, Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Wei Lian, MD

  Department of Neurosurgery, Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 21, 2023
• Study Start: May 3, 2023
• Primary Completion: April 29, 2024
• Study Completion: August 14, 2024
• Last Updated: June 8, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)