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NCT Number: NCT05822817

Comparison of Postoperative Recovery of Sevoflurane and Propofol After Transsphenoidal Surgery

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.

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Key information

Conditions

Pituitary Adenoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hypothalamic Diseases Hypothalamic Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pituitary Diseases Pituitary Neoplasms Supratentorial Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

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

Drug

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.

Primary outcomes

  1. 15-item quality of recovery score (QoR-15)

    Time frame: 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 outcomes

  1. Time to awake from anesthesia

    Time frame: From stopping sevoflurane or propofol to awake, approximately 30 minutes

    The time between discontinuing drugs and response to verbal command.

  2. Time to extubation

    Time frame: 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.

  3. Agitation or sedation level during emergence

    Time frame: 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.

  4. Coughing and bucking during emergence

    Time frame: 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.

  5. Time to discharge from postanesthesia care unit (PACU)

    Time frame: 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.

  6. PACU antiemetic drug use

    Time frame: From admit into PACU to discharge from PACU, approximately 45 minutes

    The drug use due to postoperative nausea and vomiting in PACU.

  7. PACU analgesic drug use

    Time frame: From admit into PACU to discharge from PACU, approximately 45 minutes

    The drug use due to postoperative pain in PACU.

  8. Post operative nausea and vomiting score

    Time frame: 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.

  9. Concentration of serum adrenocorticotropic hormone (ACTH)

    Time frame: 24 hours after end of surgery

    The investigators examine the serum level of ACTH in pg/mL.

  10. Concentration of serum cortisol

    Time frame: 24 hours after end of surgery

    The investigators examine the serum level of cortisol in ug/dL.

  11. Concentration of serum thyroid-stimulating hormone (TSH)

    Time frame: 24 hours after end of surgery

    The investigators examine the serum level of TSH in uIU/mL.

  12. Concentration of serum growth hormone (GH)

    Time frame: 24 hours after end of surgery

    The investigators examine the serum level of GH in ng/mL.

  13. Concentration of serum gonadotrophin

    Time frame: 24 hours after end of surgery

    The investigators examine the serum level of gonadotrophin in IU/L.

  14. Concentration of serum prolactin (PRL)

    Time frame: 24 hours after end of surgery

    The investigators examine the serum level of PRL ng/mL.

  15. Counts of peripheral blood lymphocyte

    Time frame: 24 hours after end of surgery

  16. Incidence of hypotension during anesthesia

    Time frame: 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.

  17. Incidence of hypertension during anesthesia

    Time frame: 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.

  18. Time to discharge from hospital

    Time frame: 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 outcomes

  1. Number of participants with postoperative complications

    Time frame: After the surgery till discharge

    The investigators record major postoperative complications and other complications related to anesthesia not mentioned above.

  2. Number of participants with postoperative complications

    Time frame: After discharge till 7 days after the surgery

    The investigators record major postoperative complications and other complications related to surgery and anesthesia by telephone follow-up.

  3. Numerical rating scale (NRS) pain score at postoperative day 7

    Time frame: 7 days after the surgery

    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.

  4. Post operative nausea and vomiting score at postoperative day 7

    Time frame: 7 days after the 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.

  5. Sleep quality score at postoperative day 7

    Time frame: 7 days after the surgery

    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.

  6. Appetite score at postoperative day 7

    Time frame: 7 days after the surgery

    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. 30-day readmission

    Time frame: At the 1st postoperative month

    The investigators record the patients' readmission to our hospital due to any pathological reason (to outpatient or inpatient).

  8. Concentration of serum cortisol

    Time frame: At the 3rd postoperative month

    The investigators examine the serum level of cortisol in ug/dL.

  9. Concentration of serum growth hormone (GH)

    Time frame: At the 3rd postoperative month

    The investigators examine the serum level of GH in ng/mL.

  10. Concentration of serum gonadotrophin

    Time frame: At the 3rd postoperative month

    The investigators examine the serum level of gonadotrophin in IU/L.

  11. Concentration of serum thyroid-stimulating hormone (TSH)

    Time frame: At the 3rd postoperative month

    The investigators examine the serum level of TSH in uIU/mL.

  12. Concentration of serum prolactin (PRL)

    Time frame: At the 3rd postoperative month

    The investigators examine the serum level of PRL ng/mL.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 21, 2023
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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