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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05822817
Other study ID # K3501
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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