Desflurane and Anesthesia Recovery Period in Endonasal Endoscopic Pituitary Adenoma Resection

NCT05088252 | Completed

• 1 other identifier: XUAN20211004
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Neoplasms

Outcome Measures

Primary Outcomes (1)

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

  immediately after the surgery

Study Arms (2)

Desflurane Inhalational Anesthesia

EXPERIMENTAL

Drug: Desflurane

Propofol Total Intravenous Anesthesia

ACTIVE COMPARATOR

Drug: Propofol

Interventions

Desflurane DRUG

After induction, anesthesia will be maintained with 0.7-1.0 MAC desflurane and 0.05-0.3 μg/kg/min remifentanil.

Desflurane Inhalational Anesthesia

Propofol DRUG

After induction, anesthesia will be maintained with 4-6mg/kg/h propofol and 0.05- 0.3 μg/kg/min remifentanil.

Propofol Total Intravenous Anesthesia

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Ruquan Han

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Interventions

Desflurane; 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)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 21, 2021
• Study Start: December 1, 2021
• Primary Completion: May 10, 2022
• Study Completion: May 31, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CN (1)