Female Patients Undergoing Laparoscopic Abdominal SurgeryNCT01752374
Palonestron, Granisetron and Ramosetron for Prevention of Postoperative Nasea and Voming After Laparoscopic Abdominal Surgery
An observational study of Female Patients Undergoing Laparoscopic Abdominal Surgery, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
We compared the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT3 antagonist, granisetron and ondansetron in patients at high-risk for postoperative nausea and vomiting after laparoscpic abdominal surgery. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Female Patients Undergoing Laparoscopic Abdominal Surgery
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The sample size was determined based on the ability to detect a difference in the primary outcome variable, the incidence of nausea. With 30 patients in each group there was 80% power at an a of 0.05 to detect a 30% difference in the number of patients with nausea up to 24 h after surgery.
Who may be able to join
- female gender, non-smoking and use of postoperative opioids undergoing laparocopic abdominal surgery
- Exclusion criteria included laparoscopic abdominal surgey, allergy to one of the study drugs, opioid dependence, history of gastro-intestinal disease or Parkinson's disease, history of previous PONV and motion sickness, contra-indication for epidural block (previous back surgery, bleeding diathesis or neurological dysfunction), anti-emetic medication within 24 h before surgery, inability to use the PCEA device or comprehend the visual analogue scales (VAS) for pain and nausea assessment, or unwillingness to be enrolled in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
We compared the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT3 antagonist, granisetron and ondansetron in patients at high-risk for postoperative nausea and vomiting after laparoscpic abdominal surgery.
This study was conducted to determine the efficacy of three 5-HT3 receptor antagonists in the prevention of PONV for laparoscopic surgery in patients receiving PCA IV.
Read the detailed description
Occurrences of nausea and vomiting, the severity of nausea (VAS), rescue antiemetic drug use, and amount of PCEA infusion and rescue pethidine were monitored after the end of surgery during four time periods: 0-2 h; 2-6 h; 6-24 h; and 24-48 h. Nausea was defined as the subjectively unpleasant sensation associated with awareness of the urge to vomit; vomiting included retching (defined as the laboured spastic, rhythmic contraction of the respiratory muscles without the expulsion of the gastric contents) and vomiting (defined as the forceful expulsion of gastric contents from the mouth) [11]. A complete response was defined as no PONV and no need for rescue anti-emetic drug. If two or more episodes of PONV occurred during the study period, a rescue anti-emetic (metoclopramide 10 mg) was given IV. The primary outcome was the incidence of nausea during the study period.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Palonosetron group | Patient recieving Palonosetron/granisetron and ramosetron | |
| Granisetron group | Not described | |
| Ramosetron group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of nasea
Measured: immediated postop to 48hrs after surgery
Secondary outcomes (1)
frequency of rescue drug needed
Measured: postop to 48hrs after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Female Patients Undergoing Laparoscopic Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won-Suk Lee, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752374
- Sponsor's protocol ID
- GIRBA2493
- Status last verified
- Aug 2015
- First submitted
- 16 Dec 2012
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Yoo JY, Chae YJ, Cho HB, Park KH, Kim JS, Lee SY. Comparison of the incidence of postoperative nausea and vomiting between women undergoing open or robot-assisted thyroidectomy. Surg Endosc. 2013 Apr;27(4):1321-5. doi: 10.1007/s00464-012-2607-7. Epub 2012 Dec 13.
PubMed 23239293Lee WS, Lee KB, Lim S, Chang YG. Comparison of palonosetron, granisetron, and ramosetron for the prevention of postoperative nausea and vomiting after laparoscopic gynecologic surgery: a prospective randomized trial. BMC Anesthesiol. 2015 Sep 3;15:121. doi: 10.1186/s12871-015-0102-0.
PubMed 26335706
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palonestron, Granisetron and Ramosetron for Prevention of Postoperative Nasea and Voming After Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT01752374
- Acronym / sponsor ID
- GIRBA2493
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (actual)
- First posted
- 19 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We compared the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT3 antagonist, granisetron and ondansetron in patients at high-risk for postoperative nausea and vomiting after laparoscpic abdominal surgery.
This study was conducted to determine the efficacy of three 5-HT3 receptor antagonists in the prevention of PONV for laparoscopic surgery in patients receiving PCA IV.
Detailed description
Occurrences of nausea and vomiting, the severity of nausea (VAS), rescue antiemetic drug use, and amount of PCEA infusion and rescue pethidine were monitored after the end of surgery during four time periods: 0-2 h; 2-6 h; 6-24 h; and 24-48 h. Nausea was defined as the subjectively unpleasant sensation associated with awareness of the urge to vomit; vomiting included retching (defined as the laboured spastic, rhythmic contraction of the respiratory muscles without the expulsion of the gastric contents) and vomiting (defined as the forceful expulsion of gastric contents from the mouth) [11]. A complete response was defined as no PONV and no need for rescue anti-emetic drug. If two or more episodes of PONV occurred during the study period, a rescue anti-emetic (metoclopramide 10 mg) was given IV. The primary outcome was the incidence of nausea during the study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Palonosetron group | – | –Patient recieving Palonosetron/granisetron and ramosetron |
| Granisetron group | – | – |
| Ramosetron group | – | – |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample size was determined based on the ability to detect a difference in the primary outcome variable, the incidence of nausea. With 30 patients in each group there was 80% power at an a of 0.05 to detect a 30% difference in the number of patients with nausea up to 24 h after surgery.
Key inclusion criteria (2 listed)
- female gender, non-smoking and use of postoperative opioids undergoing laparocopic abdominal surgery
- Exclusion criteria included laparoscopic abdominal surgey, allergy to one of the study drugs, opioid dependence, history of gastro-intestinal disease or Parkinson's disease, history of previous PONV and motion sickness, contra-indication for epidural block (previous back surgery, bleeding diathesis or neurological dysfunction), anti-emetic medication within 24 h before surgery, inability to use the PCEA device or comprehend the visual analogue scales (VAS) for pain and nausea assessment, or unwillingness to be enrolled in the study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
severity of nasea
Time frame: immediated postop to 48hrs after surgery
1 secondary outcome
frequency of rescue drug needed
Time frame: postop to 48hrs after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2015.
- Background: PubMed 23239293Yoo JY, Chae YJ, Cho HB, Park KH, Kim JS, Lee SY. Comparison of the incidence of postoperative nausea and vomiting between women undergoing open or robot-assisted thyroidectomy. Surg Endosc. 2013 Apr;27(4):1321-5. doi: 10.1007/s00464-012-2607-7. Epub 2012 Dec 13.
- Derived from this study: PubMed 26335706Lee WS, Lee KB, Lim S, Chang YG. Comparison of palonosetron, granisetron, and ramosetron for the prevention of postoperative nausea and vomiting after laparoscopic gynecologic surgery: a prospective randomized trial. BMC Anesthesiol. 2015 Sep 3;15:121. doi: 10.1186/s12871-015-0102-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Patients Undergoing Laparoscopic Abdominal Surgery, run by Gachon University Gil Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of nasea (time frame: immediated postop to 48hrs after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01752374, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.