Desflurane and Anesthesia Recovery Period in Endonasal Endoscopic Pituitary Adenoma Resection

June 18, 2023 updated by: Ruquan Han, Beijing Tiantan Hospital

Effects of Desflurane on the Quality of Anesthesia Recovery Period in Patients Undergoing Endonasal Endoscopic Pituitary Adenoma Resection#a Randomized Controlled Study

Nasal packing is required after endoscopic pituitary adenoma resection. The patient can only breathe through the mouth. The blood and secretion in the nasal cavity may be inhaled into the trachea after the operation. GH-secreting pituitary adenoma causes pharyngeal soft tissue and tongue hypertrophy. These conditions increase the risk of respiratory obstruction and hypoxemia during anesthesia recovery. Propofol total intravenous anesthesia has a rapid effect and a low incidence of nausea and vomiting. Patients anesthetized with desflurane recover quickly is conducive to early recovery of respiratory function and orientation. This study intends to compare the effects of desflurane and propofol on the quality of anesthesia recovery period in patients undergoing endonasal endoscopic pituitary adenoma resection and to provide clinical evidence for the use of desflurane in neurosurgical anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Ruquan Han

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-65 years;
  • Elective endoscopic transsphenoidal resection of pituitary adenomas;
  • ASA status I-III;
  • Informed consent signed by patients.

Exclusion Criteria:

  • emergency surgery;
  • complicated with cerebrovascular disease;
  • complicated with pulmonary disease, oxygen saturation below 95% without oxygen;
  • expected to retain endotracheal intubation;
  • preoperative disturbance of consciousness was not compatible with assessment;
  • complicated with primary hypothyroidism;
  • previous history of cervical surgery, burns, and radiotherapy;
  • BMI >30kg/m2;
  • invasive pituitary adenoma with Knosp grade 4.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Desflurane Inhalational Anesthesia
Drug: Desflurane
After induction, anesthesia will be maintained with 0.7-1.0 MAC desflurane and 0.05-0.3 μg/kg/min remifentanil.
Active Comparator: Propofol Total Intravenous Anesthesia
Drug: Propofol
After induction, anesthesia will be maintained with 4-6mg/kg/h propofol and 0.05- 0.3 μg/kg/min remifentanil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time required of the Aldrete score reached 9 points after drug withdrawal.
Time Frame: immediately after the surgery
immediately after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

May 10, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (Actual)

October 21, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 18, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XUAN20211004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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