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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sevoflurane | Experimental | Anesthesia is maintained with sevoflurane. |
|
| propofol | Experimental | Anesthesia is maintained with continuous infusion of propofol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time to extubation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of participants with postoperative complications |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuguang Huang, MD | Department of Anesthesiology, Peking Union Medical College Hospital | Study Chair |
| Lulu Ma, MD | Department of Anesthesiology, Peking Union Medical College Hospital | Study Director |
| Bing Xing, MD | Department of Neurosurgery, Peking Union Medical College Hospital | Principal Investigator |
| Wei Lian, MD | Department of Neurosurgery, Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17376252 | Background | 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. | |
| 19098618 | Background |
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| ID | Term |
|---|---|
| D010911 | Pituitary Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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| 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. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| PACU analgesic drug use | The drug use due to postoperative pain in PACU. | From admit into PACU to discharge from PACU, approximately 45 minutes |
| 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 |
| Concentration of serum adrenocorticotropic hormone (ACTH) | The investigators examine the serum level of ACTH in pg/mL. | 24 hours after end of surgery |
| Concentration of serum cortisol | The investigators examine the serum level of cortisol in ug/dL. | 24 hours after end of surgery |
| Concentration of serum thyroid-stimulating hormone (TSH) | The investigators examine the serum level of TSH in uIU/mL. | 24 hours after end of surgery |
| Concentration of serum growth hormone (GH) | The investigators examine the serum level of GH in ng/mL. | 24 hours after end of surgery |
| Concentration of serum gonadotrophin | The investigators examine the serum level of gonadotrophin in IU/L. | 24 hours after end of surgery |
| Concentration of serum prolactin (PRL) | The investigators examine the serum level of PRL ng/mL. | 24 hours after end of surgery |
| Counts of peripheral blood lymphocyte | 24 hours after end of surgery |
| 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 |
| 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 |
| 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 |
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Concentration of serum cortisol | The investigators examine the serum level of cortisol in ug/dL. | At the 3rd postoperative month |
| Concentration of serum growth hormone (GH) | The investigators examine the serum level of GH in ng/mL. | At the 3rd postoperative month |
| Concentration of serum gonadotrophin | The investigators examine the serum level of gonadotrophin in IU/L. | At the 3rd postoperative month |
| Concentration of serum thyroid-stimulating hormone (TSH) | The investigators examine the serum level of TSH in uIU/mL. | At the 3rd postoperative month |
| Concentration of serum prolactin (PRL) | The investigators examine the serum level of PRL ng/mL. | At the 3rd postoperative month |
| 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. |
| 35813289 | Background | 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. |
| 40760415 | Derived | 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. |
| D015173 |
| Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |