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Desflurane and Anesthesia Recovery Period in Endonasal Endoscopic Pituitary Adenoma Resection

Primary Purpose

Pituitary Neoplasms

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Desflurane
Propofol
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pituitary Neoplasms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Complicated with cerebrovascular disease;
  • Complicated with lung disease, the SpO2 is less than 95% without oxygen inhalation;
  • It is expected to retain endotracheal intubation after operation;
  • The disturbance of consciousness can not cooperate with the evaluation before operation;
  • Complicated with hypothyroidism;
  • The previous history of neck surgery, burns, radiotherapy;
  • Invasive pituitary adenomas with Knosp grade 4.

Sites / Locations

  • Ruquan Han

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Desflurane Inhalational Anesthesia

Propofol Total Intravenous Anesthesia

Arm Description

Outcomes

Primary Outcome Measures

Time required of the Aldrete score reached 9 points after drug withdrawal.

Secondary Outcome Measures

Full Information

First Posted
October 5, 2021
Last Updated
June 18, 2023
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05088252
Brief Title
Desflurane and Anesthesia Recovery Period in Endonasal Endoscopic Pituitary Adenoma Resection
Official Title
Effects of Desflurane on the Quality of Anesthesia Recovery Period in Patients Undergoing Endonasal Endoscopic Pituitary Adenoma Resection#a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Neoplasms

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desflurane Inhalational Anesthesia
Arm Type
Experimental
Arm Title
Propofol Total Intravenous Anesthesia
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
After induction, anesthesia will be maintained with 0.7-1.0 MAC desflurane and 0.05-0.3 μg/kg/min remifentanil.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
After induction, anesthesia will be maintained with 4-6mg/kg/h propofol and 0.05- 0.3 μg/kg/min remifentanil.
Primary Outcome Measure Information:
Title
Time required of the Aldrete score reached 9 points after drug withdrawal.
Time Frame
immediately after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ruquan Han
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China

12. IPD Sharing Statement

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Desflurane and Anesthesia Recovery Period in Endonasal Endoscopic Pituitary Adenoma Resection

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