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Comparison of early postoperative recovery between propofol and sevoflurane anesthesia based on intrathecal morphine pain control in living kidney donors undergoing hand assisted laparoscopic nephrectomy: a prospective randomized study

Status Approved

First Submitted Date

2019/10/14
Registered Date

2019/10/18
Last Updated Date

2020/01/18

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0004351
Unique Protocol ID	KC19MESI0573
Public/Brief Title	A study of postoperative recovery between intravenous anesthesia group and inhalation anesthesia using sevoflurane group after hand assisted laparoscopic donor nephrectomy in living donors for kidney transplantation
Scientific Title	Comparison of early postoperative recovery between propofol and sevoflurane anesthesia based on intrathecal morphine pain control in living kidney donors undergoing hand assisted laparoscopic nephrectomy: a prospective randomized study
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KC19MESI0573
Approval Date	2019-10-07
Institutional Review Board Name	Catholic Medical Center Clinical Reseach Coordinating Center
Institutional Review Board Address	222, Banpo-daero, Seocho-gu, Seoul
Institutional Review Board Telephone	02-2258-8202
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Minsuk Chae
Title	Dr
Telephone	+82-2-2258-6150
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222 BANPO-DAERO, SEOCHO-GU, SEOUL
Contact Person for Public Queries
Name	Minsuk Chae
Title	Dr
Telephone	+82-2-2258-6150
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222 BANPO-DAERO, SEOCHO-GU, SEOUL
Contact Person for Updating Information
Name	Minsuk Chae
Title	Dr
Telephone	+82-2-2258-6150
Affiliation	The Catholic University of Korea, Seoul St. Mary's Hospital
Address	222 BANPO-DAERO, SEOCHO-GU, SEOUL

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2019-10-18 Actual
Target Number of Participant	80
Primary Completion Date	2021-12-31 , Anticipated
Study Completion Date	2021-12-31 , Anticipated
Name of Study	The Catholic University of Korea, Seoul St. Mary's Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2019-10-18 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	The Catholic University of Korea, Seoul St. Mary's Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	The Catholic University of Korea, Seoul St. Mary's Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Postoperative recovery is one of the important factors in organ donors. They undergo the operation in purpose of the organ donation itself, not because of disease, fast recovery and discharge are necessary in psychological aspects in addition to the physical aspect of the donor. The purpose of this study is to evaluate the difference of degree of recovery between two groups of patients with different anesthetic drugs who get pain relief with morphine by spinal anesthesia. This will be an important data in the future for the rapid recovery and reduced complications of patients undergoing renal donation operation.

Study Summary Information

Lay Summary

Postoperative recovery is one of the important factors in organ donors. They undergo the operation in purpose of the organ donation itself, not because of disease, fast recovery and discharge are necessary in psychological aspects in addition to the physical aspect of the donor. The purpose of this study is to evaluate the difference of degree of recovery between two groups of patients with different anesthetic drugs who get pain relief with morphine by spinal anesthesia. This will be an important data in the future for the rapid recovery and reduced complications of patients undergoing renal donation operation.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Supportive Care
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Subject
Allocation	RCT
Intervention Type	Drug
Intervention Description	One group of patients undergoing general anesthesia was given continuous IV (intravenous) infusion of propofol to the effect site concentration of 3 to 5 mcg/ml using TCI (target controlled infusion) until the end of the operation. The control group received 2 to 3 vol% (1 MAC) of Sevoflurane via endotracheal tube until the end of the operation.
Number of Arms	2
Arm 1	Arm Label Propofol Total intravenous anesthesia
	Target Number of Participant 40
	Arm Type Experimental
	Arm Description Continuous infusion of Propofol IV to the effect site concentration of 3 to 5 mcg/ml using TCI until the end of the operation
Arm 2	Arm Label Sevoflurane Inhalation anesthesia
	Target Number of Participant 40
	Arm Type Active comparator
	Arm Description Maintain 2 to 3 vol% (1 MAC) of Sevoflurane via endotracheal tube until the end of the operation.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	Not Applicable-Anesthesia American Society of Anesthesiologists' physical status 1 or 2 grade
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description 1. Healthy donors scheduled to undergo kidney donation at Seoul St. Mary's Hospital 2. Donors who can be administered intrathecal morphine 3. Adults (ages 19 years or older) 4. American Society of Anesthesiologists physical status 1 or 2 grade
Exclusion Criteria	1. Patients who do not agree to participate in this study 2. Emergency surgery 3. Patient contraindicated for spinal puncture 4. Children (under 19 years old) 5. American Society of Anesthesiologists' physical status 3 or 4 grade 6. Intraoperative bleeding requires colloid or transfusion during surgery 7. Hemodynamic instability to the extent that vasoactive drugs are necessary.
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Result of quality of recovery-40 questionnaire for 24 hours after the operation
Timepoint	24 hours after the operation
Secondary Outcome(s) 1
Outcome	Total number of steps for 24 hours after operation
Timepoint	24 hours after the operation
Secondary Outcome(s) 2
Outcome	Availability of early ambulation on the day of the operation
Timepoint	6 hours after the operation
Secondary Outcome(s) 3
Outcome	Complications occurs for 24 hours after the operation
Timepoint	6 hours and 24 hours after the operation
Secondary Outcome(s) 4
Outcome	Total dose of IV PCA infused for 6 hours and 24 hours after the operation
Timepoint	6 hours and 24 hours after the operation
Secondary Outcome(s) 5
Outcome	Availability of ambulation on the day after the operation
Timepoint	24 hours after the oparation
Secondary Outcome(s) 6
Outcome	Frequency and amount of acute pain control medicine administered for 24 hours after the operation
Timepoint	24 hours after the operation
Secondary Outcome(s) 7
Outcome	Blood test results preoperative and 6 hours, 24 hours after the operation
Timepoint	The day before and 6 hours, 24 hours after the operation
Secondary Outcome(s) 8
Outcome	Clavien-Dindo surgical complication grade
Timepoint	24 hours after the oparation
Secondary Outcome(s) 9
Outcome	Todal hospital stay
Timepoint	After discharge

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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