Nausea, PostoperativeEarly Phase 1NCT04622618
Optimal Dosing of Preoperative Gabapentin for Prevention of Postoperative Nausea and Vomiting
A Early Phase 1 study testing Gabapentin in people with Nausea, Postoperative and Vomiting, Postoperative, run by Ain Shams University at 2 sites in Egypt.
Trial summary
Overall incidence of postoperative nausea and vomiting (PONV) after general anesthesia is 40-90 % . gabapentin has been incorporated into "fast-track" packages and improved recovery during surgery protocols to avoid unintended side effects associated with opioid alternatives. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Nausea, Postoperative, Vomiting, Postoperative, Pain, Postoperative
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Sep 2020to 15 Feb 2021
- Phase
- Early Phase 1
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between (18- 65) years
- ASA I-II
- scheduled for elective laparoscopic abdominal surgery.
Who cannot join
- age below 18 and above 60 years
- ASA III- IV
- pregnancy or breastfeeding
- psychiatric illness
- administration of antiemetic or systemic corticosteroids within 24 hours prior to surgery
- vomiting within 24 hours prior to surgery
Show all 12Show fewer
- alcohol or drug abuse;
- known hypersensitivity or contraindications to gabapentin
- impaired liver or kidney function
- history of motion sickness
- patients on anti-depressants
- patients on whom laparoscopic procedure converted into open technique.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
AinShams University, Faculty of medicine
Cairo, Abbasia, 11591
AinShams University, Faculty of medicine
Cairo
About this study
Official title: Optimal Dosing of Preoperative Gabapentin for Prevention of Postoperative Nausea and Vomiting After Abdominal Laparoscopic Surgery: a Randomized Prospective Comparative Study
Overall incidence of postoperative nausea and vomiting (PONV) after general anesthesia is 40-90 % . gabapentin has been incorporated into "fast-track" packages and improved recovery during surgery protocols to avoid unintended side effects associated with opioid alternatives. Interestingly, gabapentin has also been noted to reduce the effects of chemotherapy-induced nausea, effective in treatment of gravidarum hyperemesis, and postdural puncture emesis. Different dosing regimens were tested.The goal of the study is to determine the most effective dose of oral gabapentin given 1 hour prior to surgery on the occurrence and severity of PONV and drug side effects in the first 24 hours postoperatively to find the most effective dose of gabapentin with the least side effects.
Read the detailed description
A total of (150) adult patients who will undergo elective abdominal laparoscopic surgery will be included in the study. Written informed consent will be obtained from all patients before randomization. Randomization will be done with the help of a computer generated list of numbers. Patients will be divided randomly and equally into three groups (50 patients each(. The first group of patients will receive 300 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group G1), the second group of patients will receive 600 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group G2), the third group of patients will receive 900 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group G3). Drug formulation will be done by one of the researchers making the dosage of the three groups the same in number and shape of the capsules and then given to a junior anesthetist who is neither involved nor interested in any way in the sample to be administered to the patients surveyed
- Being tested
- Gabapentin
- Keywords
- gabapentin, postoperative nausea and vomiting, laparoscopic surgeries, Visual analogue scale
- Medical subject headings
- Postoperative Nausea and Vomiting, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Anticonvulsant, Antiemetic, Analgesic
| Study group | Role | What they receive |
|---|---|---|
| G 300 | Active comparator | The patients will receive 300 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water Receives: Drug: Gabapentin |
| G 600 | Active comparator | The patients will receive 600 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water Receives: Drug: Gabapentin |
| G 900 | Active comparator | The patients will receive 900 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PONV episodes (nausea, retching or vomiting)
number of attacks
Measured: at H4 (4th hour) postoperative
Incidence of PONV episodes (nausea, retching or vomiting)
number of attacks
Measured: at H12 (12th hour) postoperative
Incidence of PONV episodes (nausea, retching or vomiting)
number of attacks
Measured: at H24 (24th hour) postoperative
Severity of nausea
measured by nausea verbal numerical rating scale (NVRS) which is an eleven points scale describing nausea severity (0= no nausea, 10= worst nausea imaginable, mild nausea 1-3, moderate 4-6, or severe 7-10)
Measured: at H4 (4th hour) postoperative
Severity of nausea
measured by nausea verbal numerical rating scale (NVRS) which is an eleven points scale describing nausea severity (0= no nausea, 10= worst nausea imaginable, mild nausea 1-3, moderate 4-6, or severe 7-10)
Measured: at H12 (12th hour) postoperative
Severity of nausea
measured by nausea verbal numerical rating scale (NVRS) which is an eleven points scale describing nausea severity (0= no nausea, 10= worst nausea imaginable, mild nausea 1-3, moderate 4-6, or severe 7-10)
Measured: at H24 (24th hour) postoperative
Secondary outcomes (3)
Need for rescue antiemetic
if severe nausea or two or more emetic episodes, or upon a request from the patient to be repeated if no response within 1 hour up to 3 mg.
Measured: during the first 24 hours postoperative
Intensity of postoperative pain: Visual Analogue Scale
assessed by using an 11-points Visual Analogue Scale from 0-10 (0= no pain, 10 = worst intolerable pain, mild pain 1-3, moderate pain 4-6, or severe pain 7-10)
Measured: Total dose in (mg) given during the first 24 hours postoperative
incidence of side effects
dizziness, headache and somnolence
Measured: during the first 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start15 Sep 2020
- Primary completion20 Jan 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of (150) adult patients who will undergo elective abdominal laparoscopic surgery will be included in the study. Written informed consent will be obtained from all patients before randomization. Patients will be divided randomly and equally into three groups (50 patients each(.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Nabil Abdelrahman, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622618
- Sponsor's protocol ID
- FAMSU R 53/2020
- Status last verified
- May 2021
- First submitted
- 2 Oct 2020
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Excel sheets of the study
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Dosing of Preoperative Gabapentin for Prevention of Postoperative Nausea and Vomiting After Abdominal Laparoscopic Surgery: a Randomized Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT04622618
- Acronym / sponsor ID
- FAMSU R 53/2020
- Keywords
- gabapentin, postoperative nausea and vomiting, laparoscopic surgeries, Visual analogue scale
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 10 Nov 2020 (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.
Overall incidence of postoperative nausea and vomiting (PONV) after general anesthesia is 40-90 % . gabapentin has been incorporated into "fast-track" packages and improved recovery during surgery protocols to avoid unintended side effects associated with opioid alternatives. Interestingly, gabapentin has also been noted to reduce the effects of chemotherapy-induced nausea, effective in treatment of gravidarum hyperemesis, and postdural puncture emesis. Different dosing regimens were tested.The goal of the study is to determine the most effective dose of oral gabapentin given 1 hour prior to surgery on the occurrence and severity of PONV and drug side effects in the first 24 hours postoperatively to find the most effective dose of gabapentin with the least side effects.
Detailed description
A total of (150) adult patients who will undergo elective abdominal laparoscopic surgery will be included in the study. Written informed consent will be obtained from all patients before randomization. Randomization will be done with the help of a computer generated list of numbers. Patients will be divided randomly and equally into three groups (50 patients each(. The first group of patients will receive 300 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group G1), the second group of patients will receive 600 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group G2), the third group of patients will receive 900 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group G3). Drug formulation will be done by one of the researchers making the dosage of the three groups the same in number and shape of the capsules and then given to a junior anesthetist who is neither involved nor interested in any way in the sample to be administered to the patients surveyed
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- A total of (150) adult patients who will undergo elective abdominal laparoscopic surgery will be included in the study. Written informed consent will be obtained from all patients before randomization. Patients will be divided randomly and equally into three groups (50 patients each(.
| Arm | Type | Receives |
|---|---|---|
| G 300 | Active comparator | Drug: GabapentinThe patients will receive 300 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water |
| G 600 | Active comparator | Drug: GabapentinThe patients will receive 600 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water |
| G 900 | Active comparator | Drug: GabapentinThe patients will receive 900 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between (18- 65) years
- ASA I-II
- scheduled for elective laparoscopic abdominal surgery.
Key exclusion criteria (12 listed)
- age below 18 and above 60 years
- ASA III- IV
- pregnancy or breastfeeding
- psychiatric illness
- administration of antiemetic or systemic corticosteroids within 24 hours prior to surgery
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 |
|---|---|---|
| GabapentinAnticonvulsant, Antiemetic, Analgesic | Drug | G 300, G 600, G 900 |
Primary outcome
Incidence of PONV episodes (nausea, retching or vomiting)
Time frame: at H4 (4th hour) postoperative
number of attacks
Incidence of PONV episodes (nausea, retching or vomiting)
Time frame: at H12 (12th hour) postoperative
number of attacks
Incidence of PONV episodes (nausea, retching or vomiting)
Time frame: at H24 (24th hour) postoperative
number of attacks
Severity of nausea
Time frame: at H4 (4th hour) postoperative
measured by nausea verbal numerical rating scale (NVRS) which is an eleven points scale describing nausea severity (0= no nausea, 10= worst nausea imaginable, mild nausea 1-3, moderate 4-6, or severe 7-10)
Severity of nausea
Time frame: at H12 (12th hour) postoperative
measured by nausea verbal numerical rating scale (NVRS) which is an eleven points scale describing nausea severity (0= no nausea, 10= worst nausea imaginable, mild nausea 1-3, moderate 4-6, or severe 7-10)
Severity of nausea
Time frame: at H24 (24th hour) postoperative
measured by nausea verbal numerical rating scale (NVRS) which is an eleven points scale describing nausea severity (0= no nausea, 10= worst nausea imaginable, mild nausea 1-3, moderate 4-6, or severe 7-10)
3 secondary outcomes
Need for rescue antiemetic
Time frame: during the first 24 hours postoperative
Intensity of postoperative pain: Visual Analogue Scale
Time frame: Total dose in (mg) given during the first 24 hours postoperative
incidence of side effects
Time frame: during the first 24 hours postoperative
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 27 May 2021.
- Individual participant dataSharing planned: Yes. Excel sheets of the study
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gabapentin in people with Nausea, Postoperative and Vomiting, Postoperative, run by Ain Shams University at 2 sites in Egypt.
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 12 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 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of PONV episodes (nausea, retching or vomiting) (time frame: at H4 (4th hour) postoperative). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2021.