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Influence of sufentanil infusion on remifentanil based anesthesia

Status Approved

First Submitted Date

2013/07/03
Registered Date

2013/07/09
Last Updated Date

2015/07/08

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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	KCT0000785
Unique Protocol ID	KUH1160057
Public/Brief Title	Influence of sufentanil infusion on remifentanil based anesthesia
Scientific Title	Influence of sufentanil infusion on remifentanil based anesthesia
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KUH1160057
Approval Date	2013-06-27
Institutional Review Board Name	Institutional Review Board of Konkuk University Medical Center
Institutional Review Board Address
Institutional Review Board Telephone
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	Seong-Hyop Kim
Title	Assistant professor
Telephone	+82-2-2030-5454
Affiliation	Konkuk University Medical Center
Address
Contact Person for Public Queries
Name	Chung-Sik Oh
Title	Clinical Fellow
Telephone	+82-2-2030-5457
Affiliation	Konkuk University Medical Center
Address
Contact Person for Updating Information
Name	Chung-Sik Oh
Title	Clinical Fellow
Telephone	+82-2-2030-5457
Affiliation	Konkuk University Medical Center
Address

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	Completed
Date of First Enrollment	2013-06-27 Actual
Target Number of Participant	120
Primary Completion Date	2013-07-01 , Actual
Study Completion Date	2013-12-26 , Actual
Name of Study	Konkuk University Medical Center
Recruitment Status	Completed
Date of First Enrollment	2013-06-27 ,

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	Konkuk University Medical Center
Organization Type	Medical Institute
Project ID	KUH1160057

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Konkuk University Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	To maintain hemodynamic stability during operation, total intra-venous anesthesia, using propofol with remifentanil, was adopted universally. The dosage of propofol and remifentanil was affected by the anesthetic depth, surgical stress and so on. In general, propofol infusion dosage is adjusted by the bispectral index (BIS), and remifentanil infusion dosage is adjusted to minimize neurohormonal response to surgical stress, but remifentanil was rapidly degradated by the plasma and tissue esterase. So the more remifentanil was infused during anesthesia to preserve hemodynamic stability, the more analgesic dosage is needed after operation by increased post operative pain, which influence to hemodynamic instability. Sufentanil was opioid that have longer reaction time and effective half life than remifentanil. In previous study, desflurane inhalation and sufentanil infusion during anesthesia showed effective analgesic result without increasing post-operative nausea and vomiting. So we assumed that sufentanil infusion during late operative period, using high dose remifentanil, could be helpful to prevent post operative pain and to maintain hemodynmic stability. The purpose of this study is to access the effect of sufentanil infusion during late operative period, using high dose remifentanil, for maintaining hemodynamic stability and for reducing post operative pain.

Study Summary Information

Lay Summary

To maintain hemodynamic stability during operation, total intra-venous anesthesia, using propofol with remifentanil, was adopted universally. The dosage of propofol and remifentanil was affected by the anesthetic depth, surgical stress and so on. In general, propofol infusion dosage is adjusted by the bispectral index (BIS), and remifentanil infusion dosage is adjusted to minimize neurohormonal response to surgical stress, but remifentanil was rapidly degradated by the plasma and tissue esterase. So the more remifentanil was infused during anesthesia to preserve hemodynamic stability, the more analgesic dosage is needed after operation by increased post operative pain, which influence  to hemodynamic instability. Sufentanil was opioid that have longer reaction time and effective half life than remifentanil. In previous study, desflurane inhalation and sufentanil infusion during anesthesia showed effective analgesic result without increasing post-operative nausea and vomiting. So we assumed that sufentanil infusion during late operative period, using high dose remifentanil, could be helpful to prevent post operative pain and to maintain hemodynmic stability. The purpose of this study is to access the effect of sufentanil infusion during late operative period, using high dose remifentanil, for maintaining hemodynamic stability and for reducing post operative pain.

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	Treatment
Phase	Phase4
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator, Caregiver, Outcome Accessor
Allocation	RCT
Intervention Type	Drug
Intervention Description	After procuration of surgical specimen, sufentanil (S group) or normal saline (C group) will be infused intravenously at target concentration 0.15 ng/ml until extubation. The 50 ml syringe filled with sufentanil 5 ml (250 mg) and normal saline 45 ml (S group), or only normal saline 50 ml (C group) for TCI
Number of Arms	2
Arm 1	Arm Label Group C
	Target Number of Participant 60
	Arm Type Placebo comparator
	Arm Description After procuration of surgical specimen, normal saline will be infused intravenously at target concentration 0.15 ng/ml until extubation. The 50 ml syringe filled with normal saline 50ml for TCI. Total infused dosage will be recorded.
Arm 2	Arm Label Group S
	Target Number of Participant 60
	Arm Type Experimental
	Arm Description After procuration of surgical specimen, sufentanil will be infused intravenously at target concentration 0.15 ng/ml until extubation. The 50 ml syringe filled with sufentanil 5 ml (250 mg)for TCI. Total infused dosage will be recorded.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	Not Applicable-Anesthesia
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 20Year~85Year
	Description Patients undergoing gynaecologic laparoscopic surgery with intravenous patient controlled analgesia (PCA) for postoperative pain control were enrolled. The patients were American Society of Anesthesiologists Patient Status (ASA PS) I or II, and at least 20 years old
Exclusion Criteria	1) urgent or emergent case 2) re-do case 3) allergy to egg or soybean oil 4) QT prolongation in preoperative electrocardiography 5) history of drug abuse 6) receiving current medications 7) concurrent other surgery 8) surgery within 1 hour 9) discharge within 72 hours
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	Efficacy
Outcome	pain score via Visual Analog Scale
Timepoint	Extubation. Arrival at PACU. 24,48,72 hours after discharge from PACU
Primary Outcome(s) 2
Outcome	mean blood pressure, heart rate
Timepoint	extubation time of endotracheal tube
Secondary Outcome(s) 1
Outcome	post operative nausea and vomiting
Timepoint	Extubation. Arrival at PACU. 24,48,72 hours after discharge from PACU

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

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	Not provided at time of Registration

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