임상연구정보서비스

Search: Search

The effect of using nefopam in patient controlled analgesia on postoperative nausea and vomiting in patient undergoing laparoscopic surgery

Status Approved

First Submitted Date

2018/12/17
Registered Date

2019/03/25
Last Updated Date

2019/03/08

Move list page

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	KCT0003659
Unique Protocol ID	KHNMC 2018-10-018-001
Public/Brief Title	The effect of using nefopam in patient controlled analgesia on postoperative nausea and vomiting in patient undergoing laparoscopic surgery
Scientific Title	The effect of using nefopam in patient controlled analgesia on postoperative nausea and vomiting in patient undergoing laparoscopic surgery
Acronym	nefopam and PONV
MFDS Regulated Study	Yes
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	KHNMC 2018-10-018-001
Approval Date	2018-12-26
Institutional Review Board Name	Kyung Hee University Hosipital at Gangdong IRB
Institutional Review Board Address	892, Dongnam-ro, Gangdong-gu, Seoul
Institutional Review Board Telephone	02-440-8107
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	Hyungseok Seo
Title	조교수
Telephone	+82-2-440-7809
Affiliation	Kyung Hee University Hospital at Gangdong
Address	KUIMS, 892, DONGNAM-RO, GANGDONG-GU, SEOUL, KOREA
Contact Person for Public Queries
Name	Yoonju Go
Title	전공의
Telephone	+82-2-440-7809
Affiliation	Kyung Hee University Hospital at Gangdong
Address	KUIMS, 892, DONGNAM-RO, GANGDONG-GU, SEOUL, KOREA
Contact Person for Updating Information
Name	Yoonju Go
Title	전공의
Telephone	+82-2-440-7809
Affiliation	Kyung Hee University Hospital at Gangdong
Address	KUIMS, 892, DONGNAM-RO, GANGDONG-GU, SEOUL, KOREA

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	2018-12-31 Actual
Target Number of Participant	178
Primary Completion Date	2019-06-25 , Anticipated
Study Completion Date	2019-06-25 , Anticipated
Name of Study	Kyung Hee University Hospital at Gangdong
Recruitment Status	Recruiting
Date of First Enrollment	2018-12-31 ,

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	Kyung Hee University Hospital at Gangdong
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kyung Hee University Hospital at Gangdong
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Laparoscopic surgery is minimal invasive procedure and it has advantages of decreased postoperative pain and fast recovoery and shortened hospital stay. In the growing numbers of surgical procedure, laparoscopic approach becomes the first choice. However, recent studies suggest that laparoscopic,gynecological surgery, and cholecystectomy are risk factors that independently increase the risk for postoperative nausea and vomiting (PONV). The incidence of PONV is 20-30 % and in high-risk patients, the PONV rate can be reached as 80 %. PONV is one of common postoperative complications and it is associated with distress to patients, poor quality of recovery and increased hospital stay. A number of risk factors, including patient-specific risk factors, type of surgery, anesthetic agents and opioids, have been shown simple association with an increased incidence of PONV. According to Apfel score, which is widely used tool for PONV risk stratification, female, nonsmoker, the history of PONV and postoperative analgegics rise the possibility. Type of surgery is not independent and consistent risk factor for PONV incidence, however, gynecological surgery is subject to female which increse the possibility of PONV according to Apfel score. Patient controlled analgesia(PCA) with opioid fentanyl is widely used for analgesia for pain control in the early postoperative recovery. As side effect of fentanyl, nausea and vomiting is reported 20 %up to 60 %. Current PCA regimen has become lowering opioid and adding non-opioid analgesics to reduce opioid side effect. Nefopam is a non-opioid, non-steroidal, centrally acting analgesic thought to act via multiple mechanisms different to opioid and NSAIDs including potent inhibition of monoamine reuptake and NMDA(N-methyl-Daspartate) receptor, which regulates the transmission of glutamate. Previous research was revealed that co-administration of nefopam and fentanyl showed 40-60% fentanyl-sparing effect and reduced side effect of opioids including respiratoty distress. However, the clinical evidence of co-administration of nefopam and fentanyl has not been fully evaluated in the patient at the moderate to severe PONV risk. Therefore, this study examined the effect of adding nefopam as fentanyl equivalent in fentanyl-based PCA regimen on the incidence of postoperative nausea and vomiting, compared to fentanyl-only PCA regimen in patient undergoing laparoscopic surgery.

Study Summary Information

Lay Summary

Laparoscopic surgery is minimal invasive procedure and it has advantages of decreased postoperative pain and fast recovoery and shortened hospital stay. In the growing numbers of surgical procedure, laparoscopic approach becomes the first choice. However, recent studies suggest that laparoscopic,gynecological surgery, and cholecystectomy are risk factors that independently increase the risk for postoperative nausea and vomiting (PONV). The incidence of PONV is 20-30 &#37; and in high-risk patients, the PONV rate can be reached as 80 &#37;. PONV is one of common postoperative complications and it is associated with distress to patients, poor quality of recovery and increased hospital stay. A number of risk factors, including patient-specific risk factors, type of surgery, anesthetic agents and opioids, have been shown simple association with an increased incidence of PONV. According to Apfel score, which is widely used tool for PONV risk stratification, female, nonsmoker, the history of PONV and postoperative analgegics rise the possibility. Type of surgery is not independent and consistent risk factor for PONV incidence, however, gynecological surgery is subject to female which increse the possibility of PONV according to Apfel score.

Patient controlled analgesia(PCA) with opioid fentanyl is widely used for analgesia for pain control in the early postoperative recovery. As side effect of fentanyl, nausea and vomiting is reported 20 &#37;up to 60 &#37;. Current PCA regimen has become lowering opioid and adding non-opioid analgesics to reduce opioid side effect. Nefopam is a non-opioid, non-steroidal, centrally acting analgesic thought to act via multiple mechanisms different to opioid and NSAIDs including potent inhibition of monoamine reuptake and NMDA(N-methyl-Daspartate) receptor, which regulates the transmission of glutamate. Previous research was revealed that co-administration of nefopam and fentanyl showed 40-60&#37; fentanyl-sparing effect and reduced side effect of opioids including respiratoty distress. However, the clinical evidence of co-administration of nefopam and fentanyl has not been fully evaluated in the patient at the moderate to severe PONV risk.

Therefore, this study examined the effect of adding nefopam as fentanyl equivalent in fentanyl-based PCA regimen on the incidence of postoperative nausea and vomiting, compared to fentanyl-only PCA regimen in patient undergoing laparoscopic surgery.

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	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Drug
Intervention Description	F group: fentanyl 20 ㎍/kg + ramosetron 0.6 mg + normal saline (total volume: 100ml) N group: fentanyl 10 ㎍/kg + nefopam 200mg + ramosetron 0.6 mg + normal saline (total volume: 100ml) PCA device(Patient-Controlled Analgesia device) setting: total volume: 100ml , basal infusion rate 1 ml/hr, bolus 1 ml, lock out time 15mins
Number of Arms	2
Arm 1	Arm Label Fentanyl only group(F group)
	Target Number of Participant 89
	Arm Type Active comparator
	Arm Description F group: fentanyl 20 ㎍/kg + ramosetron 0.6 mg + normal saline (total volume: 100ml)
Arm 2	Arm Label Nefopam group(N group)
	Target Number of Participant 89
	Arm Type Experimental
	Arm Description N group: fentanyl 10 ㎍/kg + nefopam 200mg + ramosetron 0.6 mg + normal saline (total volume: 100ml)

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (N00-N99)Diseases of the genitourinary system (N85.9)Noninflammatory disorder of uterus, unspecified Genital Diseases, Female
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 19Year~74Year
	Description ① Female patient aged 19 to 74 years undergoing scheduled gynecological laparoscopic surgery ② American Society of Anesthesiologist Physical Status I, II or III ③ Moderate to severe PONV risk according to Apfel score(female gender, non-smoker, history of PONV, postoperative opioids)
Exclusion Criteria	① BMI<18.5 kg/m2 or BMI >35 kg/m2 ② Uncontrolled DM (HbA1c > 6.5%) ③ Patients with severe comorbidity who need to reduce the amount of fentanyl
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	/Safety/Efficacy
Outcome	PONV, PONV_VAS
Timepoint	30mins or 1 hour after arriving of PACU(Post-anesthesia care unit), postop 24hours
Primary Outcome(s) 2
Outcome	vomiting
Timepoint	30mins or 1 hour after arriving of PACU(Post-anesthesia care unit), postop 24hours
Secondary Outcome(s) 1
Outcome	Pain score_VAS
Timepoint	On arriving of PACU, 30mins and 1 hour after arriving of PACU(Post-anesthesia care unit), postop 24hours
Secondary Outcome(s) 2
Outcome	Quality of Recovery 15
Timepoint	postop 24hours
Secondary Outcome(s) 3
Outcome	PCA comsuption
Timepoint	1 hour after arriving of PACU(Post-anesthesia care unit), postop 24hours

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

Move list page Move to top