Comparison of Postoperative Recovery of Sevoflurane and Propofol After Transsphenoidal Surgery

Pituitary Adenoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05822817
• Other study ID #: K3501
• Status: Recruiting
• Phase: Phase 4
• Start date: May 3, 2023
• Est. completion date: April 2024

Study information

• Verified date: April 2024
• Source: Peking Union Medical College Hospital
• Contact: Lulu Ma, MD
• Phone: 0086-13811049619
• Email: malulu[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Men or women, aged from 18 to 70

2. American Society of Anesthesiologists (ASA) class I - III

3. Patients scheduled for transsphenoidal surgery requiring general anesthesia managed with endotracheal intubation

Exclusion Criteria:

1. Patients allergic or contraindicated to sevoflurane, propofol, or other drugs used during surgery

2. Severe pulmonary disease, saturation of peripheral oxygen (SpO2) < 90%

3. Severe nervous system disease with consciousness disorder

4. Patients scheduled for intensive care unit (ICU) after surgery

5. Pregnancy

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with postoperative complications	The investigators record major postoperative complications and other complications related to anesthesia not mentioned above.	After the surgery till discharge
Other	Number of participants with postoperative complications	The investigators record major postoperative complications and other complications related to surgery and anesthesia by telephone follow-up.	After discharge till 7 days after the surgery
Other	Numerical rating scale (NRS) pain score at postoperative day 7	The investigators record NRS pain score (0 to 10, higher the more painful) of patients on the 7th day after the surgery by telephone follow-up.	7 days after the surgery
Other	Post operative nausea and vomiting score at postoperative day 7	Score: 0, no nausea and vomiting; 1-4, mild nausea and vomiting; 5-6, moderate nausea and vomiting; 7-10, severe nausea and vomiting.	7 days after the surgery
Other	Sleep quality score at postoperative day 7	The investigators record the sleep quality score (0 to 10, higher the better) of patients on the 7th day after the surgery by telephone follow-up.	7 days after the surgery
Other	Appetite score at postoperative day 7	The investigators record the appetite score (0 to 10, higher the better) of patients on the 7th day after the surgery by telephone follow-up.	7 days after the surgery
Other	30-day readmission	The investigators record the patients' readmission to our hospital due to any pathological reason (to outpatient or inpatient).	At the 1st postoperative month
Other	Concentration of serum cortisol	The investigators examine the serum level of cortisol in ug/dL.	At the 3rd postoperative month
Other	Concentration of serum growth hormone (GH)	The investigators examine the serum level of GH in ng/mL.	At the 3rd postoperative month
Other	Concentration of serum gonadotrophin	The investigators examine the serum level of gonadotrophin in IU/L.	At the 3rd postoperative month
Other	Concentration of serum thyroid-stimulating hormone (TSH)	The investigators examine the serum level of TSH in uIU/mL.	At the 3rd postoperative month
Other	Concentration of serum prolactin (PRL)	The investigators examine the serum level of PRL ng/mL.	At the 3rd postoperative month
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	PACU analgesic drug use	The drug use due to postoperative pain in PACU.	From admit into PACU to discharge from PACU, approximately 45 minutes
Secondary	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
Secondary	Concentration of serum adrenocorticotropic hormone (ACTH)	The investigators examine the serum level of ACTH in pg/mL.	24 hours after end of surgery
Secondary	Concentration of serum cortisol	The investigators examine the serum level of cortisol in ug/dL.	24 hours after end of surgery
Secondary	Concentration of serum thyroid-stimulating hormone (TSH)	The investigators examine the serum level of TSH in uIU/mL.	24 hours after end of surgery
Secondary	Concentration of serum growth hormone (GH)	The investigators examine the serum level of GH in ng/mL.	24 hours after end of surgery
Secondary	Concentration of serum gonadotrophin	The investigators examine the serum level of gonadotrophin in IU/L.	24 hours after end of surgery
Secondary	Concentration of serum prolactin (PRL)	The investigators examine the serum level of PRL ng/mL.	24 hours after end of surgery
Secondary	Counts of peripheral blood lymphocyte		24 hours after end of surgery
Secondary	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
Secondary	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
Secondary	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