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Effect of Ramosetron on Bowel Motility After Gynecological Surgery

Primary Purpose

Postoperative Nausea and Vomiting

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ramosetron
Normal saline
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring PONV, digestive signs and symptoms, vomiting, antiemetics, nausea, ramosetron

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 20-70 yrs of age
  • ASA(American Society of Anesthesiologists) physical status class I or II
  • Scheduled for gynecological laparoscopic surgery

Exclusion Criteria:

  • Allergic to study drugs
  • Antiemetics or steroids use within 24 hrs prior to surgery
  • Dependence upon opioids
  • Insulin dependent Diabetes Mellitus
  • Cardiovascular or pulmonary disease
  • Renal or hepatic insufficiency
  • BMI>=35kg/m2
  • History of motion sickness or PONV
  • Cigarette smoker
  • Conversion to open laparotomy from laparoscopic surgery
  • Pregnants

Sites / Locations

  • Kyung Hee University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ramosetron

Control

Arm Description

2 ml of normal saline iv before induction, ramosetron 0.3 mg iv at the end of surgery, ramosetron 0.6 mg added to the iv PCA(Patient-Controlled Analgesia)

dexamethasone 10 mg iv before induction, 2 ml of normal saline iv at the end of surgery, 4 ml of normal saline added to the iv PCA

Outcomes

Primary Outcome Measures

Time from surgery to the passage of first flatus

Secondary Outcome Measures

Time to first defecation
Incidence of postoperative ileus

Full Information

First Posted
July 27, 2016
Last Updated
January 11, 2017
Sponsor
Kyunghee University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02849483
Brief Title
Effect of Ramosetron on Bowel Motility After Gynecological Surgery
Official Title
Effect of Ramosetron on Postoperative Restoration of Bowel Motility After Gynecological Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Ramosetron is effective in preventing postoperative nausea and vomiting. Several studies reported that ramosetron is also effective treatment of irritable bowel syndrome. The investigators examine the effect of ramosetron on postoperative bowel motility.
Detailed Description
Ramosetron, a new potent and long-acting selective 5-HT3(5-hydroxytryptamine3) receptor anatagonist, is effective for preventing postoperative nausea and vomiting. Also several studies reported that ramosetron is effective treatment of diarrhea-predominant irritable bowel syndrome because it inhibits the accelerated colonic transit, abnormal colonic water transport, defecation abnormality, and the lowered colonic perceptual threshold by corticotrophin-releasing hormone, There is no study about the effect of ramosetron used for preventing postoperative nausea and vomiting on postoperative bowel motility. In this study, the investigators examine the effect of ramosetron on postoperative bowel motility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
PONV, digestive signs and symptoms, vomiting, antiemetics, nausea, ramosetron

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ramosetron
Arm Type
Experimental
Arm Description
2 ml of normal saline iv before induction, ramosetron 0.3 mg iv at the end of surgery, ramosetron 0.6 mg added to the iv PCA(Patient-Controlled Analgesia)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
dexamethasone 10 mg iv before induction, 2 ml of normal saline iv at the end of surgery, 4 ml of normal saline added to the iv PCA
Intervention Type
Drug
Intervention Name(s)
Ramosetron
Other Intervention Name(s)
Nasea
Intervention Description
Administer 2 ml of normal saline iv before induction. Inject ramosetron 0.3 mg iv at the end of surgery. Add ramosetron 0.6 mg to the iv PCA.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Administer dexamethasone 10 mg iv before induction. Inject 2 ml of normal saline iv at the end of surgery. Add 4 ml of normal saline to the iv PCA.
Primary Outcome Measure Information:
Title
Time from surgery to the passage of first flatus
Time Frame
Within 10 days after surgery
Secondary Outcome Measure Information:
Title
Time to first defecation
Time Frame
Within 10 days after surgery
Title
Incidence of postoperative ileus
Time Frame
Within 10 days after surgery
Other Pre-specified Outcome Measures:
Title
Incidence and severity of postoperative nausea
Time Frame
0-6 hours, 6-24 hours, and 24-48 hours after surgery
Title
Incidence and severity of postoperative vomiting
Time Frame
0-6 hours, 6-24 hours, and 24-48 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 20-70 yrs of age ASA(American Society of Anesthesiologists) physical status class I or II Scheduled for gynecological laparoscopic surgery Exclusion Criteria: Allergic to study drugs Antiemetics or steroids use within 24 hrs prior to surgery Dependence upon opioids Insulin dependent Diabetes Mellitus Cardiovascular or pulmonary disease Renal or hepatic insufficiency BMI>=35kg/m2 History of motion sickness or PONV Cigarette smoker Conversion to open laparotomy from laparoscopic surgery Pregnants
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youngsoon Kim, M.D., Ph.D.
Phone
+82-958-8589
Email
ys.kim@khu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mi Kyeong Kim, M.D., Ph.D.
Organizational Affiliation
Kyunghee University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youngsoon Kim
Phone
958-8589
Email
ys.kim@khu.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34614204
Citation
Kang HY, Kim Y, You AH, Kim YJ, Kim MK. A randomized controlled trial of the effect of ramosetron on postoperative restoration of bowel motility after gynecologic laparoscopic surgery. Int J Gynaecol Obstet. 2022 Jul;158(1):172-178. doi: 10.1002/ijgo.13969. Epub 2021 Oct 16.
Results Reference
derived

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Effect of Ramosetron on Bowel Motility After Gynecological Surgery

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