Comparison of Postoperative Recovery of Sevoflurane and Propofol After Transsphenoidal Surgery
- Registration Number
- NCT05822817
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 252
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sevoflurane sevoflurane Anesthesia is maintained with sevoflurane. propofol propofol Anesthesia is maintained with continuous infusion of propofol.
- Primary Outcome Measures
Name Time Method 15-item quality of recovery score (QoR-15) 24 hours after end of surgery 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.
- Secondary Outcome Measures
Name Time Method Time to awake from anesthesia From stopping sevoflurane or propofol to awake, approximately 30 minutes The time between discontinuing drugs and response to verbal command.
Time to extubation From stopping sevoflurane or propofol to recovery of spontaneous breathing and withdrawal of tracheal tube, approximately 30 minutes The time between discontinuing drugs and withdrawal of tracheal tube.
Coughing and bucking during emergence From stopping sevoflurane or propofol to complete awakening, approximately 30 minutes Coughing score ranges from 0 to 3, and a higher score indicates a severer outcome.The investigators record the highest coughing score during emergence.
Time to discharge from postanesthesia care unit (PACU) From admit into PACU to discharge from PACU, approximately 45 minutes The time between admission into PACU and discharging from PACU with Aldrete score over 9. Aldrete score ranges from 0 to 10, and a higher score indicates a better recovery from anesthesia.
Concentration of serum growth hormone (GH) 24 hours after end of surgery The investigators examine the serum level of GH in ng/mL.
Incidence of hypotension during anesthesia From start of surgery to end of surgery, on an average of 2 hours Hypotension is defined as decrease of mean arterial pressure (MAP) more than 20% of baseline.
Concentration of serum thyroid-stimulating hormone (TSH) 24 hours after end of surgery The investigators examine the serum level of TSH in uIU/mL.
Concentration of serum prolactin (PRL) 24 hours after end of surgery The investigators examine the serum level of PRL ng/mL.
Counts of peripheral blood lymphocyte 24 hours after end of surgery Agitation or sedation level during emergence From stopping sevoflurane or propofol to complete awakening, approximately 30 minutes The highest Richmond agitation and sedation scale score (RASS) during emergence. The RASS score ranges from -5 to +4, and a lower score indicates a more sedative level.
PACU antiemetic drug use From admit into PACU to discharge from PACU, approximately 45 minutes The drug use due to postoperative nausea and vomiting in PACU.
PACU analgesic drug use From admit into PACU to discharge from PACU, approximately 45 minutes The drug use due to postoperative pain in PACU.
Post operative nausea and vomiting score 24 hours after end of surgery Score: 0, no nausea and vomiting; 1-4, mild nausea and vomiting; 5-6, moderate nausea and vomiting; 7-10, severe nausea and vomiting.
Concentration of serum adrenocorticotropic hormone (ACTH) 24 hours after end of surgery The investigators examine the serum level of ACTH in pg/mL.
Concentration of serum cortisol 24 hours after end of surgery The investigators examine the serum level of cortisol in ug/dL.
Concentration of serum gonadotrophin 24 hours after end of surgery The investigators examine the serum level of gonadotrophin in IU/L.
Incidence of hypertension during anesthesia From start of surgery to end of surgery, on an average of 2 hours Hypertension is defined as increase of MAP more than 20% of baseline.
Time to discharge from hospital From end of surgery to discharge from hospital, on an average of 2 days The time between end of surgery and discharge from hospital.
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China