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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05088252
Other study ID # XUAN20211004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date May 31, 2022

Study information

Verified date June 2023
Source Beijing Tiantan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date May 31, 2022
Est. primary completion date May 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Desflurane
After induction, anesthesia will be maintained with 0.7-1.0 MAC desflurane and 0.05-0.3 µg/kg/min remifentanil.
Propofol
After induction, anesthesia will be maintained with 4-6mg/kg/h propofol and 0.05- 0.3 µg/kg/min remifentanil.

Locations

Country Name City State
China Ruquan Han Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time required of the Aldrete score reached 9 points after drug withdrawal. immediately after the surgery
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