Comparison of Postoperative Recovery of Sevoflurane and Propofol After Transsphenoidal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized Controlled Study to Compare the Effect of Sevoflurane and Propofol for Maintenance of Anesthesia on Postoperative Recovery After Transsphenoidal Resection of Pituitary Adenoma

Conditions
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Pituitary Adenoma

Intervention / Treatment
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* Drug: sevoflurane
* Drug: propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sevoflurane<br>Anesthesia is maintained with sevoflurane. | Drug: sevoflurane<br>* Anesthesia is maintained with inhalation of sevoflurane. The concentration of sevoflurane was adjusted to maintain anesthetic depth, aiming for a bispectral index of 40-60.<br>|
| Experimental: propofol<br>Anesthesia is maintained with continuous infusion of propofol. | Drug: propofol<br>* Anesthesia is maintained with an effect-site target-controlled infusion of propofol (2-6ug/ml) based on the Marsh mode. The concentration of propofol was adjusted to maintain anesthetic depth, aiming for a bispectral index of 40-60.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 15-item quality of recovery score (QoR-15) | 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. | 24 hours after end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to awake from anesthesia | The time between discontinuing drugs and response to verbal command. | From stopping sevoflurane or propofol to awake, approximately 30 minutes | 
| Time to extubation | The time between discontinuing drugs and withdrawal of tracheal tube. | From stopping sevoflurane or propofol to recovery of spontaneous breathing and withdrawal of tracheal tube, approximately 30 minutes | 
| Agitation or sedation level during emergence | 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. | From stopping sevoflurane or propofol to complete awakening, approximately 30 minutes | 
| Coughing and bucking during emergence | Coughing score ranges from 0 to 3, and a higher score indicates a severer outcome.The investigators record the highest coughing score during emergence. | From stopping sevoflurane or propofol to complete awakening, approximately 30 minutes | 
| Time to discharge from postanesthesia care unit (PACU) | 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. | From admit into PACU to discharge from PACU, approximately 45 minutes | 
| PACU antiemetic drug use | The drug use due to postoperative nausea and vomiting in PACU. | From admit into PACU to discharge from PACU, approximately 45 minutes | 
| PACU analgesic drug use | The drug use due to postoperative pain in PACU. | From admit into PACU to discharge from PACU, approximately 45 minutes | 
| Post operative nausea and vomiting score | Score: 0, no nausea and vomiting; 1-4, mild nausea and vomiting; 5-6, moderate nausea and vomiting; 7-10, severe nausea and vomiting. | 24 hours after end of surgery | 
| Concentration of serum adrenocorticotropic hormone (ACTH) | The investigators examine the serum level of ACTH in pg/mL. | 24 hours after end of surgery | 
| Concentration of serum cortisol | The investigators examine the serum level of cortisol in ug/dL. | 24 hours after end of surgery | 
| Concentration of serum thyroid-stimulating hormone (TSH) | The investigators examine the serum level of TSH in uIU/mL. | 24 hours after end of surgery | 
| Concentration of serum growth hormone (GH) | The investigators examine the serum level of GH in ng/mL. | 24 hours after end of surgery | 
| Concentration of serum gonadotrophin | The investigators examine the serum level of gonadotrophin in IU/L. | 24 hours after end of surgery | 
| Concentration of serum prolactin (PRL) | The investigators examine the serum level of PRL ng/mL. | 24 hours after end of surgery | 
| Counts of peripheral blood lymphocyte |  | 24 hours after end of surgery | 
| Incidence of hypotension during anesthesia | Hypotension is defined as decrease of mean arterial pressure (MAP) more than 20% of baseline. | From start of surgery to end of surgery, on an average of 2 hours | 
| Incidence of hypertension during anesthesia | Hypertension is defined as increase of MAP more than 20% of baseline. | From start of surgery to end of surgery, on an average of 2 hours | 
| Time to discharge from hospital | The time between end of surgery and discharge from hospital. | From end of surgery to discharge from hospital, on an average of 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Transsphenoidal surgery, Enhanced recovery after surgery