GabapentinEarly Phase 1NCT05301205
Perioperative Administration of Gabapentin for Reducing Inhalational Anesthetic Consumption
A Early Phase 1 study testing oral gabapentin in people with Gabapentin, run by Cairo University at 1 site in Egypt.
Trial summary
Gabapentin, a structural analog of gamma aminobutyric acid (GABA), was introduced within the us as an anticonvulsant, used clinically to treat epilepsy. The drug causes amino acids release within the medulla spinalis dorsal horn and thus decreasing response to neural inputs and stabilizing the nervous activity. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gabapentin
- What is being tested?
- oral gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jun 2021to 30 Jul 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
- Inclusion criteria:
- Patients aged from 18 to 60 years.
- ASA I-II.
- Undergoing craniotomy for intracranial tumors.
- Exclusion criteria:
- Patient refusal
- Patients younger than 18 or above 60 years old
- patients with (ASA) physical status ≥ III
- patients with compromised cardiovascular, renal, hepatic or neurological function
- Known allergy to study drug.
- Contraindication or chronic use (consistent use for longer than 3 months) to any of the study drugs
- Suffered from severe psychiatric disease or drug addiction;
- History of parenteral or oral analgesic intake within the last 48hours
Trial locations and contacts
1 site in 1 country.
About this study
Gabapentin, a structural analog of gamma aminobutyric acid (GABA), was introduced within the us as an anticonvulsant, used clinically to treat epilepsy. The drug causes amino acids release within the medulla spinalis dorsal horn and thus decreasing response to neural inputs and stabilizing the nervous activity. The mechanism of action of gabapentin on neuropathic pain is assumed to bind to the alpha 2 delta subunit of the voltage-dependent calcium channel within the central systema nervosum , reducing calcium influx into the nerve terminals and decreases the release of neurotransmitters like glutamate . Gabapentin, therefore, can be used for controlling chronic pain, as in diabetic neuropathy and other neuropathic disorders . Some studies examined the effectiveness of gabapentin for acute postoperative pain management for gynecological surgery, lumbar spinal surgery, arthroplasty, and thoracic surgery . A recent study concluded that gabapentin has a role in preoperative anxiolysis, attenuation of hemodynamic response to intubation, prevention of postoperative nausea and vomiting (PONV) and finally postoperative delirium . Up to date, the effect of preoperative gabapentin on inhaled anesthetic depth is unknown
- Conditions
- Gabapentin
- Being tested
- oral gabapentin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral gabapentinDrug
will be received oral gabapentin capsule 2 HOURS pre-operatively.
| Study group | Role | What they receive |
|---|---|---|
| group I | Active comparator | will be received oral gabapentin capsule 1200 mg 2h pre-operatively. Receives: Drug: oral gabapentin |
| group II | Active comparator | will be received oral gabapentin capsule 600 mg 2h pre-operatively. Receives: Drug: oral gabapentin |
| Group III | No intervention | will be received placebo capsules at 2 hours preoperatively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sevoflurane consumption
Intra-operative consumption of sevoflurane will be measured and recorded (ml/hr).
Measured: 4 hours
Secondary outcomes (2)
nalbuphine consumption
postoperative nalbuphine consumption by mg
Measured: 24 hours
Intraoperative fentanyl consumption.
Intraoperative fentanyl consumption by mic
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start25 Jun 2021
- Primary completion13 Jun 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GabapentinStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Samir Wahdan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301205
- Sponsor's protocol ID
- N-48-2021
- Status last verified
- Mar 2022
- First submitted
- 19 Mar 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: still working
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Administration of Gabapentin for Reducing Inhalational Anesthetic Consumption
- ClinicalTrials.gov ID
- NCT05301205
- Acronym / sponsor ID
- N-48-2021
- Conditions
- Gabapentin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 13 Jun 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 29 Mar 2022 (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.
Gabapentin, a structural analog of gamma aminobutyric acid (GABA), was introduced within the us as an anticonvulsant, used clinically to treat epilepsy. The drug causes amino acids release within the medulla spinalis dorsal horn and thus decreasing response to neural inputs and stabilizing the nervous activity. The mechanism of action of gabapentin on neuropathic pain is assumed to bind to the alpha 2 delta subunit of the voltage-dependent calcium channel within the central systema nervosum , reducing calcium influx into the nerve terminals and decreases the release of neurotransmitters like glutamate . Gabapentin, therefore, can be used for controlling chronic pain, as in diabetic neuropathy and other neuropathic disorders . Some studies examined the effectiveness of gabapentin for acute postoperative pain management for gynecological surgery, lumbar spinal surgery, arthroplasty, and thoracic surgery . A recent study concluded that gabapentin has a role in preoperative anxiolysis, attenuation of hemodynamic response to intubation, prevention of postoperative nausea and vomiting (PONV) and finally postoperative delirium . Up to date, the effect of preoperative gabapentin on inhaled anesthetic depth is unknown
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group I | Active comparator | Drug: oral gabapentinwill be received oral gabapentin capsule 1200 mg 2h pre-operatively. |
| group II | Active comparator | Drug: oral gabapentinwill be received oral gabapentin capsule 600 mg 2h pre-operatively. |
| Group III | No intervention | –will be received placebo capsules at 2 hours preoperatively. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| oral gabapentinwill be received oral gabapentin capsule 2 HOURS pre-operatively. | Drug | group I, group II |
Primary outcome
sevoflurane consumption
Time frame: 4 hours
Intra-operative consumption of sevoflurane will be measured and recorded (ml/hr).
2 secondary outcomes
nalbuphine consumption
Time frame: 24 hours
Intraoperative fentanyl consumption.
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: Undecided. still working
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Healthy
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?
A Early Phase 1 study testing oral gabapentin in people with Gabapentin, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Mar 2022. 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 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?
Results are not available in the source record.
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?
sevoflurane consumption (time frame: 4 hours). 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 29 Mar 2022.