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Comparison of Postoperative Recovery of Sevoflurane and Propofol After Transsphenoidal Surgery

Primary Purpose

Pituitary Adenoma

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
sevoflurane
propofol
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pituitary Adenoma focused on measuring Anesthesia, Transsphenoidal surgery, Enhanced recovery after surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

sevoflurane

propofol

Arm Description

Anesthesia is maintained with sevoflurane.

Anesthesia is maintained with continuous infusion of propofol.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to awake from anesthesia
The time between discontinuing drugs and response to verbal command.
Time to extubation
The time between discontinuing drugs and withdrawal of tracheal tube.
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.
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.
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.
PACU antiemetic drug use
The drug use due to postoperative nausea and vomiting in PACU.
PACU analgesic drug use
The drug use due to postoperative pain in PACU.
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.
Concentration of serum adrenocorticotropic hormone (ACTH)
The investigators examine the serum level of ACTH in pg/mL.
Concentration of serum cortisol
The investigators examine the serum level of cortisol in ug/dL.
Concentration of serum thyroid-stimulating hormone (TSH)
The investigators examine the serum level of TSH in uIU/mL.
Concentration of serum growth hormone (GH)
The investigators examine the serum level of GH in ng/mL.
Concentration of serum gonadotrophin
The investigators examine the serum level of gonadotrophin in IU/L.
Concentration of serum prolactin (PRL)
The investigators examine the serum level of PRL ng/mL.
Counts of peripheral blood lymphocyte
Incidence of hypotension during anesthesia
Hypotension is defined as decrease of mean arterial pressure (MAP) more than 20% of baseline.
Incidence of hypertension during anesthesia
Hypertension is defined as increase of MAP more than 20% of baseline.
Time to discharge from hospital
The time between end of surgery and discharge from hospital.

Full Information

First Posted
March 13, 2023
Last Updated
May 4, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05822817
Brief Title
Comparison of Postoperative Recovery of Sevoflurane and Propofol After Transsphenoidal Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Adenoma
Keywords
Anesthesia, Transsphenoidal surgery, Enhanced recovery after surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
252 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sevoflurane
Arm Type
Experimental
Arm Description
Anesthesia is maintained with sevoflurane.
Arm Title
propofol
Arm Type
Experimental
Arm Description
Anesthesia is maintained with continuous infusion of propofol.
Intervention Type
Drug
Intervention Name(s)
sevoflurane
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Description
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 Outcome Measure Information:
Title
15-item quality of recovery score (QoR-15)
Description
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.
Time Frame
24 hours after end of surgery
Secondary Outcome Measure Information:
Title
Time to awake from anesthesia
Description
The time between discontinuing drugs and response to verbal command.
Time Frame
From stopping sevoflurane or propofol to awake, approximately 30 minutes
Title
Time to extubation
Description
The time between discontinuing drugs and withdrawal of tracheal tube.
Time Frame
From stopping sevoflurane or propofol to recovery of spontaneous breathing and withdrawal of tracheal tube, approximately 30 minutes
Title
Agitation or sedation level during emergence
Description
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.
Time Frame
From stopping sevoflurane or propofol to complete awakening, approximately 30 minutes
Title
Coughing and bucking during emergence
Description
Coughing score ranges from 0 to 3, and a higher score indicates a severer outcome.The investigators record the highest coughing score during emergence.
Time Frame
From stopping sevoflurane or propofol to complete awakening, approximately 30 minutes
Title
Time to discharge from postanesthesia care unit (PACU)
Description
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.
Time Frame
From admit into PACU to discharge from PACU, approximately 45 minutes
Title
PACU antiemetic drug use
Description
The drug use due to postoperative nausea and vomiting in PACU.
Time Frame
From admit into PACU to discharge from PACU, approximately 45 minutes
Title
PACU analgesic drug use
Description
The drug use due to postoperative pain in PACU.
Time Frame
From admit into PACU to discharge from PACU, approximately 45 minutes
Title
Post operative nausea and vomiting score
Description
Score: 0, no nausea and vomiting; 1-4, mild nausea and vomiting; 5-6, moderate nausea and vomiting; 7-10, severe nausea and vomiting.
Time Frame
24 hours after end of surgery
Title
Concentration of serum adrenocorticotropic hormone (ACTH)
Description
The investigators examine the serum level of ACTH in pg/mL.
Time Frame
24 hours after end of surgery
Title
Concentration of serum cortisol
Description
The investigators examine the serum level of cortisol in ug/dL.
Time Frame
24 hours after end of surgery
Title
Concentration of serum thyroid-stimulating hormone (TSH)
Description
The investigators examine the serum level of TSH in uIU/mL.
Time Frame
24 hours after end of surgery
Title
Concentration of serum growth hormone (GH)
Description
The investigators examine the serum level of GH in ng/mL.
Time Frame
24 hours after end of surgery
Title
Concentration of serum gonadotrophin
Description
The investigators examine the serum level of gonadotrophin in IU/L.
Time Frame
24 hours after end of surgery
Title
Concentration of serum prolactin (PRL)
Description
The investigators examine the serum level of PRL ng/mL.
Time Frame
24 hours after end of surgery
Title
Counts of peripheral blood lymphocyte
Time Frame
24 hours after end of surgery
Title
Incidence of hypotension during anesthesia
Description
Hypotension is defined as decrease of mean arterial pressure (MAP) more than 20% of baseline.
Time Frame
From start of surgery to end of surgery, on an average of 2 hours
Title
Incidence of hypertension during anesthesia
Description
Hypertension is defined as increase of MAP more than 20% of baseline.
Time Frame
From start of surgery to end of surgery, on an average of 2 hours
Title
Time to discharge from hospital
Description
The time between end of surgery and discharge from hospital.
Time Frame
From end of surgery to discharge from hospital, on an average of 2 days
Other Pre-specified Outcome Measures:
Title
Number of participants with perioperative complications
Description
The investigators record major perioperative complications and other complications related to anesthesia not mentioned above.
Time Frame
Intraoperative period and postoperative period (after the surgery till discharge, an average of 2 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lulu Ma, MD
Phone
0086-13811049619
Email
malulu@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yunying Feng, MDc
Phone
0086-15011178092
Email
Feng_Yunying@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuguang Huang, MD
Organizational Affiliation
Department of Anesthesiology, Peking Union Medical College Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lulu Ma, MD
Organizational Affiliation
Department of Anesthesiology, Peking Union Medical College Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bing Xing, MD
Organizational Affiliation
Department of Neurosurgery, Peking Union Medical College Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Lian, MD
Organizational Affiliation
Department of Neurosurgery, Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lulu Ma, MD
Phone
13811049619
Email
malulu@pumch.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17376252
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.
Results Reference
background
PubMed Identifier
19098618
Citation
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.
Results Reference
background
PubMed Identifier
35813289
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.
Results Reference
background

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Comparison of Postoperative Recovery of Sevoflurane and Propofol After Transsphenoidal Surgery

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