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Pituitary AdenomaPhase 4NCT05822817

Comparison of Postoperative Recovery of Sevoflurane and Propofol After Transsphenoidal Surgery

A Phase 4 study testing sevoflurane and propofol in people with Pituitary Adenoma, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pituitary Adenoma
What is being tested?
sevoflurane and propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
1 siteChina
Study dates
3 May 2023to 14 Aug 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

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

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.

Being tested
sevoflurane, propofol
Keywords
Anesthesia, Transsphenoidal surgery, Enhanced recovery after surgery
Medical subject headings
Pituitary Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sevofluraneDrug

    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.

  • propofolDrug

    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.

Study groups in NCT05822817
Study groupRoleWhat they receive
sevofluraneExperimentalAnesthesia is maintained with sevoflurane.
Receives: Drug: sevoflurane
propofolExperimentalAnesthesia is maintained with continuous infusion of propofol.
Receives: Drug: propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 hours after end of surgery

Secondary outcomes (18)

  1. Time to awake from anesthesia

    The time between discontinuing drugs and response to verbal command.

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

  2. Time to extubation

    The time between discontinuing drugs and withdrawal of tracheal tube.

    Measured: From stopping sevoflurane or propofol to recovery of spontaneous breathing and withdrawal of tracheal tube, approximately 30 minutes

  3. 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.

    Measured: From stopping sevoflurane or propofol to complete awakening, approximately 30 minutes

  4. 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.

    Measured: From stopping sevoflurane or propofol to complete awakening, approximately 30 minutes

  5. 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.

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

  6. PACU antiemetic drug use

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

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

  7. PACU analgesic drug use

    The drug use due to postoperative pain in PACU.

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

  8. 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.

    Measured: 24 hours after end of surgery

  9. Concentration of serum adrenocorticotropic hormone (ACTH)

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

    Measured: 24 hours after end of surgery

  10. Concentration of serum cortisol

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

    Measured: 24 hours after end of surgery

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

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

    Measured: 24 hours after end of surgery

  12. Concentration of serum growth hormone (GH)

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

    Measured: 24 hours after end of surgery

  13. Concentration of serum gonadotrophin

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

    Measured: 24 hours after end of surgery

  14. Concentration of serum prolactin (PRL)

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

    Measured: 24 hours after end of surgery

  15. Counts of peripheral blood lymphocyte

    Measured: 24 hours after end of surgery

  16. Incidence of hypotension during anesthesia

    Hypotension is defined as decrease of mean arterial pressure (MAP) more than 20% of baseline.

    Measured: From start of surgery to end of surgery, on an average of 2 hours

  17. Incidence of hypertension during anesthesia

    Hypertension is defined as increase of MAP more than 20% of baseline.

    Measured: From start of surgery to end of surgery, on an average of 2 hours

  18. Time to discharge from hospital

    The time between end of surgery and discharge from hospital.

    Measured: From end of surgery to discharge from hospital, on an average of 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2023
  2. Study start3 May 2023
  3. Primary completion29 Apr 2024
  4. Study completion14 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05822817
Sponsor's protocol ID
K3501
Status last verified
Apr 2024
First submitted
13 Mar 2023
Last updated
8 Jun 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17376252

  • 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.

    PubMed 19098618

  • 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.

    PubMed 35813289

  • Feng Y, Zhang Y, Lian W, Xue Y, Ma M, Yu X, Guo X, Ma L, Xing B, Huang Y. A randomized controlled trial to compare the effects of sevoflurane and propofol for maintenance of anesthesia on postoperative recovery quality in patients undergoing transsphenoidal resection of pituitary adenoma. BMC Anesthesiol. 2025 Aug 4;25(1):392. doi: 10.1186/s12871-025-03263-z.

    PubMed 40760415

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing sevoflurane and propofol in people with Pituitary Adenoma, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

15-item quality of recovery score (QoR-15) (time frame: 24 hours after end of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05822817, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.

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