Postoperative Nausea and VomitingPONVNCT02617121
The Effects of Gabapentin and Ramosetron on Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgery
A study testing Gabapentin, Ramosetron and Gabapentin and Ramosetron in people with Postoperative Nausea and Vomiting, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
This study was designed to compare the effects of gabapentin and ramosetron on PONV in patients undergoing laparoscopic gynecologic surgery. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Gabapentin, Ramosetron and Gabapentin and Ramosetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to Oct 2016
- Phase
- Interventional
- 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 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with ASA physical status 1 and 2 between 20 and 65 years undergoing laparoscopic gynecological surgery with patient-controlled analgesia for postoperative pain control.
Who cannot join
- Pregnant women
- Patients who took sedatives, antiemetics, hypnotics, analgesics, steroid, or gabapentin
- Patients with neurological deficits
- Patients with history of drug abuse and allergy of study drugs
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, KS009
About this study
Official title: Comparison of the Prophylactic Anti-emetic Efficacy of Gabapentin and Ramosetron in Patients Undergoing Laparoscopic Gynecological Surgery
This study was designed to compare the effects of gabapentin and ramosetron on PONV in patients undergoing laparoscopic gynecologic surgery.
Read the detailed description
Postoperative nausea and vomiting (PONV) in the postanesthesia care unit is a common occurrence after general anesthesia. And laparoscopic gynecological surgery is associated with a high incidence of PONV. Several antiemetic agents such as dopaminergic, histaminic and 5-HT3 antagonist (including ondansetron, ramosetron, granisetron) have been used to prevent PONV. Gabapentin, anti-convulsant, has been shown to decrease PONV, as well as chemotherapy induced nausea and vomiting in recent studies, although the exact mechanism against PONV is not known. The purpose of this study was to compare the efficacy of gabapentin and ramosetron in preventing PONV in patients undergoing laparoscopic gynecological surgery.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Gabapentin, Ramosetron, Gabapentin and Ramosetron
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Neurontin
oral gabapentin 300 mg 1 hour before induction of anesthesia
RamosetronDrug
Also called Nasea
ramosetron 0.3 mg iv at end of surgery
Gabapentin and RamosetronDrug
Also called Neurontin and Nasea
oral gabapentin 300 mg 1 hour before induction of anesthesia and ramosetron 0.3 mg iv at end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Active comparator | oral gabapentin 300 mg 1 hours before induction of anesthesia Receives: Drug: Gabapentin |
| ramosetron | Active comparator | ramosetron 0.3 mg iv at end of surgery Receives: Drug: Ramosetron |
| Gabapentin and ramosetron | Active comparator | oral gabapentin 300 mg 1 hours before induction of anesthesia ramosetron 0.3 mg iv at end of surgery Receives: Drug: Gabapentin and Ramosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and vomiting
The incidence of postoperative nausea and vomiting will be assessed during 48 hours after surgery
Measured: 48 hours postoperative
Secondary outcomes (5)
Severity of nausea
The severity of nausea will be assessed using verbal rating scales (VRS 11-points scales: 0=no nausea to 10=nausea as bad as it could be)
Measured: 48 hours postoperative
pain score
The pain score will be assessed using verbal rating scales (VRS 11-points scales: 0=none to 10=most severe)
Measured: 48 hours postoperative
sedation score
The sedation score will be assessed using verbal rating scales (VRS 11-points scales:0=none to 10=most severe)
Measured: 48 hours postoperative
patient's overall satisfaction score
The patient's overall satisfaction score will be assessed using 5 point scales (5=very satisfied, 4=somewhat satisfied, 3=neither satisfied nor dissatisfied, 2=somewhat dissatisfied, 1=very dissatisfied)
Measured: 48 hours postoperative
side effects
The side effects such as somnolence, dizziness, headache, tremor, diplopia and nystagmus will be assessed and treated
Measured: 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617121
- Sponsor's protocol ID
- HallymUMC
- Acronym
- PONV
- Status last verified
- Nov 2015
- First submitted
- 18 Nov 2015
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim KM, Huh J, Lee SK, Park EY, Lee JM, Kim HJ. Combination of gabapentin and ramosetron for the prevention of postoperative nausea and vomiting after gynecologic laparoscopic surgery: a prospective randomized comparative study. BMC Anesthesiol. 2017 May 19;17(1):65. doi: 10.1186/s12871-017-0357-8.
PubMed 28525981
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Prophylactic Anti-emetic Efficacy of Gabapentin and Ramosetron in Patients Undergoing Laparoscopic Gynecological Surgery
- ClinicalTrials.gov ID
- NCT02617121
- Acronym / sponsor ID
- PONV / HallymUMC
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 30 Nov 2015 (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.
This study was designed to compare the effects of gabapentin and ramosetron on PONV in patients undergoing laparoscopic gynecologic surgery.
Detailed description
Postoperative nausea and vomiting (PONV) in the postanesthesia care unit is a common occurrence after general anesthesia. And laparoscopic gynecological surgery is associated with a high incidence of PONV. Several antiemetic agents such as dopaminergic, histaminic and 5-HT3 antagonist (including ondansetron, ramosetron, granisetron) have been used to prevent PONV. Gabapentin, anti-convulsant, has been shown to decrease PONV, as well as chemotherapy induced nausea and vomiting in recent studies, although the exact mechanism against PONV is not known. The purpose of this study was to compare the efficacy of gabapentin and ramosetron in preventing PONV in patients undergoing laparoscopic gynecological surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Active comparator | Drug: Gabapentinoral gabapentin 300 mg 1 hours before induction of anesthesia |
| ramosetron | Active comparator | Drug: Ramosetronramosetron 0.3 mg iv at end of surgery |
| Gabapentin and ramosetron | Active comparator | Drug: Gabapentin and Ramosetronoral gabapentin 300 mg 1 hours before induction of anesthesia ramosetron 0.3 mg iv at end of surgery |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with ASA physical status 1 and 2 between 20 and 65 years undergoing laparoscopic gynecological surgery with patient-controlled analgesia for postoperative pain control.
Key exclusion criteria (4 listed)
- Pregnant women
- Patients who took sedatives, antiemetics, hypnotics, analgesics, steroid, or gabapentin
- Patients with neurological deficits
- Patients with history of drug abuse and allergy of study drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinAlso: Neurontinoral gabapentin 300 mg 1 hour before induction of anesthesia | Drug | Gabapentin |
| RamosetronAlso: Nasearamosetron 0.3 mg iv at end of surgery | Drug | ramosetron |
| Gabapentin and RamosetronAlso: Neurontin and Naseaoral gabapentin 300 mg 1 hour before induction of anesthesia and ramosetron 0.3 mg iv at end of surgery | Drug | Gabapentin and ramosetron |
Primary outcome
Incidence of postoperative nausea and vomiting
Time frame: 48 hours postoperative
The incidence of postoperative nausea and vomiting will be assessed during 48 hours after surgery
5 secondary outcomes
Severity of nausea
Time frame: 48 hours postoperative
pain score
Time frame: 48 hours postoperative
sedation score
Time frame: 48 hours postoperative
patient's overall satisfaction score
Time frame: 48 hours postoperative
side effects
Time frame: 48 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
- Derived from this study: PubMed 28525981Kim KM, Huh J, Lee SK, Park EY, Lee JM, Kim HJ. Combination of gabapentin and ramosetron for the prevention of postoperative nausea and vomiting after gynecologic laparoscopic surgery: a prospective randomized comparative study. BMC Anesthesiol. 2017 May 19;17(1):65. doi: 10.1186/s12871-017-0357-8.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin, Ramosetron and Gabapentin and Ramosetron in people with Postoperative Nausea and Vomiting, run by Hallym University 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung Mi Kim, M.D. (+82-31-380-3945, sumsonyo@hallym.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative nausea and vomiting (time frame: 48 hours postoperative). 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 NCT02617121, which also lists 1 linked publication.
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 30 Nov 2015.