Postoperative ComplicationsNCT03202459
Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
A study testing Group A - gabapentin 600 mg and Group B - pregabalin in people with Postoperative Complications and Postoperative Nausea and Vomiting, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
Trial summary
Postoperative nausea and vomiting (PONV) is one of the most commonly reported adverse effects of anesthesia. The general incidence of vomiting is approximately 30%, nausea at 50% and the PONV rate can go up to 80% in high-risk patients without prophylaxis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Complications, Postoperative Nausea and Vomiting
- What is being tested?
- Group A - gabapentin 600 mg and Group B - pregabalin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Mar 2017to 31 Jan 2018
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing laparoscopic procedures
- Apfel Score 0, I, II, III and IV
- ASA I / II
Who cannot join
- Patients with surgery converted to open before thirty minutes of surgery
- Patients who were exposed previously to gabapentin or pregabalin Patients who have allergy to any medicine used in the study
- Patient who have to any cognitive impairment
- Illiterate patients
- Patients who refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, 01221-020
Thiago Ramos Grigio, Master, +55 11 99298-1605, grigiotr@gmail.com
Ligia Andrade da Silva Telles Mathias, Doctor
About this study
Postoperative nausea and vomiting (PONV) is one of the most commonly reported adverse effects of anesthesia. The general incidence of vomiting is approximately 30%, nausea at 50% and the PONV rate can go up to 80% in high-risk patients without prophylaxis. Prevention of these episodes in high-risk patients improves satisfaction and well-being rates. Therefore, it becomes important the adequate control of PONV, aiming at the satisfaction of the patient with the procedure, lower costs for the health system as well as reduction of complications in the postoperative period. This study aims to evaluate the association of gabapentin or pregabalin with dexamethasone in reducing the incidence of PONV in high-risk patients undergoing laparoscopic surgeries in the first 48 hours postoperatively as well as to assess side effects.
Read the detailed description
The study included 60 patients at high risk for PONV (Apfel-score 0, I, II, III and IV) scheduled for elective laparoscopic surgeries at the Central Surgical Center of Irmandade da Santa Casa de Misericórdia in São Paulo. Inclusion criteria will be ASA I or II of either sex, in the age range of 18 to 70 years. In this study, the recruited patients will be allocated randomly into three groups. The group A will receive oral 600 mg gabapentin 2 h before surgery. The group B will receive oral 150 mg pregabalin 2 h before surgery. The Group C will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery. This study is "double-blind", in which neither the doctor nor the patient knows what medicine is being given.
- Being tested
- Group A - gabapentin 600 mg, Group B - pregabalin, Group C - placebo
- Keywords
- Anesthesia, Complications, Nausea, Vomiting
- Medical subject headings
- Postoperative Complications, Postoperative Nausea and Vomiting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A - gabapentin 600 mgDrug
The patient will receive oral 600 mg gabapentin 2 h before surgery
Group B - pregabalinDrug
The patient will receive oral pregabalin 150 mg 2 h before surgery
Group C - placeboDrug
The patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Group A - gabapentin | Active comparator | The patient will receive oral 600 mg gabapentin 2 h before surgery Receives: Drug: Group A - gabapentin 600 mg |
| Active Comparator: Group B - pregabalin | Active comparator | The patient will receive oral pregabalin 150 mg 2 h before surgery Receives: Drug: Group B - pregabalin |
| Placebo Comparator: Group C - placebo | Placebo comparator | The patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery Receives: Drug: Group C - placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Nausea or vomiting M0
The occurrence of postoperative nausea or vomiting, in the recovery room, during the first hour after surgery
Measured: 1 hours
Postoperative Nausea or vomiting M12
The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 12 hours after surgery
Measured: 12 hours
Postoperative Nausea or vomiting M24
The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 24 hours after surgery
Measured: 24 hours
Postoperative Nausea or vomiting M48
The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 48 hours after surgery
Measured: 48 hours
Secondary outcomes (8)
Patient demographic data
With a questionnaire will be studied the variables: age, sex, weight, height, BMI
Measured: Before surgery
Surgical Duration
Time of surgery
Measured: First hour after surgery
Duration of postoperative anesthesia stay
Time to postoperative anesthesia care unit discharge alive (hours)
Measured: First hours after surgery
The length of stay in hospital
Time of stay in hospital
Measured: From end of surgery until hospital discharge or 30 days after surgery
Time to request the first medication for nausea and vomiting
Reported by the patient or by a healthcare provider
Measured: First hour after surgery
Amount of medication
Reported by a healthcare provider
Measured: During the first 30 days after surgery
Postoperative complications
Postoperative complications after surgery
Measured: During the first 30 days after surgery
Degree of patient satisfaction
The patient's overall satisfaction will be assessed using point scales (very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied)
Measured: Before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start2 Mar 2017
- Primary completion30 Sep 2017 (estimated)
- Study completion31 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lígia Andrade da Silva Telles mathias, Faculdade de Ciências Médicas da Santa Casa de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202459
- Sponsor's protocol ID
- 56057116.0.0000.5479
- Status last verified
- Jun 2017
- First submitted
- 23 Jun 2017
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002.
PubMed 24356162Pandey CK, Priye S, Ambesh SP, Singh S, Singh U, Singh PK. Prophylactic gabapentin for prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: a randomized, double-blind, placebo-controlled study. J Postgrad Med. 2006 Apr-Jun;52(2):97-100.
PubMed 16679671Grant MC, Lee H, Page AJ, Hobson D, Wick E, Wu CL. The Effect of Preoperative Gabapentin on Postoperative Nausea and Vomiting: A Meta-Analysis. Anesth Analg. 2016 Apr;122(4):976-85. doi: 10.1213/ANE.0000000000001120.
PubMed 26991615Chandrakantan A, Glass PS. Multimodal therapies for postoperative nausea and vomiting, and pain. Br J Anaesth. 2011 Dec;107 Suppl 1:i27-40. doi: 10.1093/bja/aer358.
PubMed 22156268
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxy of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT03202459
- Acronym / sponsor ID
- 56057116.0.0000.5479
- Keywords
- Anesthesia, Complications, Nausea, Vomiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Faculdade de Ciências Médicas da Santa Casa de São PauloUniversity, hospital or other
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 30 Sep 2017 (estimated)
- Study completion
- 31 Jan 2018 (estimated)
- First posted
- 28 Jun 2017 (actual)
- 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.
Postoperative nausea and vomiting (PONV) is one of the most commonly reported adverse effects of anesthesia. The general incidence of vomiting is approximately 30%, nausea at 50% and the PONV rate can go up to 80% in high-risk patients without prophylaxis. Prevention of these episodes in high-risk patients improves satisfaction and well-being rates. Therefore, it becomes important the adequate control of PONV, aiming at the satisfaction of the patient with the procedure, lower costs for the health system as well as reduction of complications in the postoperative period. This study aims to evaluate the association of gabapentin or pregabalin with dexamethasone in reducing the incidence of PONV in high-risk patients undergoing laparoscopic surgeries in the first 48 hours postoperatively as well as to assess side effects.
Detailed description
The study included 60 patients at high risk for PONV (Apfel-score 0, I, II, III and IV) scheduled for elective laparoscopic surgeries at the Central Surgical Center of Irmandade da Santa Casa de Misericórdia in São Paulo. Inclusion criteria will be ASA I or II of either sex, in the age range of 18 to 70 years. In this study, the recruited patients will be allocated randomly into three groups. The group A will receive oral 600 mg gabapentin 2 h before surgery. The group B will receive oral 150 mg pregabalin 2 h before surgery. The Group C will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery. This study is "double-blind", in which neither the doctor nor the patient knows what medicine is being given.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Group A - gabapentin | Active comparator | Drug: Group A - gabapentin 600 mgThe patient will receive oral 600 mg gabapentin 2 h before surgery |
| Active Comparator: Group B - pregabalin | Active comparator | Drug: Group B - pregabalinThe patient will receive oral pregabalin 150 mg 2 h before surgery |
| Placebo Comparator: Group C - placebo | Placebo comparator | Drug: Group C - placeboThe patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing laparoscopic procedures
- Apfel Score 0, I, II, III and IV
- ASA I / II
Key exclusion criteria (5 listed)
- Patients with surgery converted to open before thirty minutes of surgery
- Patients who were exposed previously to gabapentin or pregabalin Patients who have allergy to any medicine used in the study
- Patient who have to any cognitive impairment
- Illiterate patients
- Patients who refuse to participate in the study
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 |
|---|---|---|
| Group A - gabapentin 600 mgThe patient will receive oral 600 mg gabapentin 2 h before surgery | Drug | Active Comparator: Group A - gabapentin |
| Group B - pregabalinThe patient will receive oral pregabalin 150 mg 2 h before surgery | Drug | Active Comparator: Group B - pregabalin |
| Group C - placeboThe patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery | Drug | Placebo Comparator: Group C - placebo |
Primary outcome
Postoperative Nausea or vomiting M0
Time frame: 1 hours
The occurrence of postoperative nausea or vomiting, in the recovery room, during the first hour after surgery
Postoperative Nausea or vomiting M12
Time frame: 12 hours
The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 12 hours after surgery
Postoperative Nausea or vomiting M24
Time frame: 24 hours
The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 24 hours after surgery
Postoperative Nausea or vomiting M48
Time frame: 48 hours
The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 48 hours after surgery
8 secondary outcomes
Patient demographic data
Time frame: Before surgery
Surgical Duration
Time frame: First hour after surgery
Duration of postoperative anesthesia stay
Time frame: First hours after surgery
The length of stay in hospital
Time frame: From end of surgery until hospital discharge or 30 days after surgery
Time to request the first medication for nausea and vomiting
Time frame: First hour after surgery
Amount of medication
Time frame: During the first 30 days after surgery
Postoperative complications
Time frame: During the first 30 days after surgery
Degree of patient satisfaction
Time frame: Before discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Results publication: PubMed 24356162Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002.
- Results publication: PubMed 16679671Pandey CK, Priye S, Ambesh SP, Singh S, Singh U, Singh PK. Prophylactic gabapentin for prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: a randomized, double-blind, placebo-controlled study. J Postgrad Med. 2006 Apr-Jun;52(2):97-100.
- Results publication: PubMed 26991615Grant MC, Lee H, Page AJ, Hobson D, Wick E, Wu CL. The Effect of Preoperative Gabapentin on Postoperative Nausea and Vomiting: A Meta-Analysis. Anesth Analg. 2016 Apr;122(4):976-85. doi: 10.1213/ANE.0000000000001120.
- Results publication: PubMed 22156268Chandrakantan A, Glass PS. Multimodal therapies for postoperative nausea and vomiting, and pain. Br J Anaesth. 2011 Dec;107 Suppl 1:i27-40. doi: 10.1093/bja/aer358.
- Individual participant dataSharing planned: No
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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 Group A - gabapentin 600 mg and Group B - pregabalin in people with Postoperative Complications and Postoperative Nausea and Vomiting, run by Faculdade de Ciências Médicas da Santa Casa de São Paulo at 1 site in Brazil.
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 3 inclusion and 5 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 28 Jun 2017. 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 Brazil. 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. Some participants in this study may receive a placebo. 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 Ligia Andrade da Silva Telles Mathias, Doctor (+ 55 11 99386-0059, rtimao@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Nausea or vomiting M0 (time frame: 1 hours). The study lists 4 primary outcomes in all. 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 NCT03202459, which also lists 4 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 28 Jun 2017.