Comparison of Postoperative Recovery of Sevoflurane and Propofol After Transsphenoidal Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: sevoflurane Anesthesia is maintained with sevoflurane. |
Drug: sevoflurane
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.
|
| Experimental: propofol Anesthesia is maintained with continuous infusion of propofol. |
Drug: propofol
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
- 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 thyroid-stimulating hormone (TSH) [24 hours after end of surgery]
The investigators examine the serum level of TSH in uIU/mL.
- Concentration of serum growth hormone (GH) [24 hours after end of surgery]
The investigators examine the serum level of GH in ng/mL.
- Concentration of serum gonadotrophin [24 hours after end of surgery]
The investigators examine the serum level of gonadotrophin in IU/L.
- 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]
- 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.
- 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.
Other Outcome Measures
- Number of participants with perioperative complications [Intraoperative period and postoperative period (after the surgery till discharge, an average of 2 days)]
The investigators record major perioperative complications and other complications related to anesthesia not mentioned above.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Study Chair: Yuguang Huang, MD, Department of Anesthesiology, Peking Union Medical College Hospital
- Study Director: Lulu Ma, MD, Department of Anesthesiology, Peking Union Medical College Hospital
- Principal Investigator: Bing Xing, MD, Department of Neurosurgery, Peking Union Medical College Hospital
- Principal Investigator: Wei Lian, MD, Department of Neurosurgery, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Ali Z, Prabhakar H, Bithal PK, Dash HH. Bispectral index-guided administration of anesthesia for transsphenoidal resection of pituitary tumors: a comparison of 3 anesthetic techniques. J Neurosurg Anesthesiol. 2009 Jan;21(1):10-5. doi: 10.1097/ANA.0b013e3181855732.
- Cafiero T, Cavallo LM, Frangiosa A, Burrelli R, Gargiulo G, Cappabianca P, de Divitiis E. Clinical comparison of remifentanil-sevoflurane vs. remifentanil-propofol for endoscopic endonasal transphenoidal surgery. Eur J Anaesthesiol. 2007 May;24(5):441-6. doi: 10.1017/S0265021506002080. Epub 2007 Mar 12.
- Kim DH, Min KT, Kim EH, Choi YS, Choi SH. Comparison of the effects of inhalational and total intravenous anesthesia on quality of recovery in patients undergoing endoscopic transsphenoidal pituitary surgery: a randomized controlled trial. Int J Med Sci. 2022 Jun 13;19(6):1056-1064. doi: 10.7150/ijms.72758. eCollection 2022.
- K3501