Elective Surgical PatientsPhase 1/2NCT06705101
Gabapentin and Pressor Response to Intubation
A Phase 1/2 study testing Gabapentin Group (Group G): Patients will receive 300 mg of oral Gabapentin in people with Elective Surgical Patients and Blood Pressure, run by Liaquat National Hospital & Medical College.
Trial summary
This study evaluates the effectiveness of oral gabapentin in reducing the pressor response (increased MAP, HR, and BP) during laryngoscopic intubation. It is a prospective, double-blind randomized controlled trial involving 144 patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Elective Surgical Patients, Blood Pressure
- What is being tested?
- Gabapentin Group (Group G): Patients will receive 300 mg of oral Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to 16 Jul 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I or II patients (American Society of Anesthesiologists Physical Status Classification).
- Age between 18 and 59 years.
- Scheduled for elective surgery under general anesthesia with endotracheal intubation.
Who cannot join
- Anticipated difficult intubation.
- ASA III or greater.
- Patients with hiatus hernia or gastro-esophageal reflux disease (GERD).
- Body weight more than 20% of ideal body weight.
- Patients on antihypertensive drugs, sedatives, hypnotics, or antidepressants.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
AEMAN ZUBAIR Dr, FCPS I contact
About this study
Official title: GABAPENTIN ATTENUATES THE PRESSOR RESPONSE TO DIRECT LARYNGOSCOPY AND TRACHEAL INTUBATION
This study evaluates the effectiveness of oral gabapentin in reducing the pressor response (increased MAP, HR, and BP) during laryngoscopic intubation. It is a prospective, double-blind randomized controlled trial involving 144 patients undergoing elective surgery. Gabapentin 300 mg or placebo will be administered preoperatively, with hemodynamic parameters monitored before and after intubation. The study aims to determine if gabapentin attenuates the sympathetic stress response compared to placebo.
Read the detailed description
Laryngoscopic tracheal intubation often triggers a significant sympathetic response, causing increased heart rate, blood pressure, and other hemodynamic changes, which can pose risks for patients with underlying cardiovascular or cerebrovascular conditions. While various methods and drugs have been employed to mitigate this pressor response, gabapentin-a GABA analog with multimodal effects-has shown promise in reducing such hemodynamic stress. This study aims to evaluate the effectiveness of oral gabapentin as a pretreatment to attenuate the sympathetic response during intubation.
The objective of this study is to compare the effectiveness of gabapentin versus placebo in reducing stress responses, such as mean arterial pressure (MAP), heart rate (HR), and blood pressure (BP), during general anesthesia with endotracheal intubation.
Study Design is Prospective, double-blind, randomized controlled trial and will be conducted in Department of Anesthesia, Liaquat National Hospital.
during 8 months. 144 patients (72 per group), calculated based on prior MAP data, with patients randomized into Gabapentin (Group G) and Placebo (Group P) Patients aged 18-59 years, ASA I or II, undergoing elective surgeries will be included.
Exclusion Criteria is difficult intubation, ASA III or higher, obesity, or use of antihypertensive or sedative drugs.
Participants will receive either 300 mg oral gabapentin or placebo 2 hours before surgery. Standard monitoring and anesthesia protocols will be followed, with blood pressure and heart rate recorded at baseline, 2 minutes, and 5 minutes post-intubation. The primary outcome is MAP, while secondary outcomes include systolic/diastolic BP and HR. Intravenous metoprolol will be administered if required for pressor responses.
SPSS v25 will be used for statistical analysis, with independent t-tests for quantitative data and chi-square tests for categorical variables. A p-value <0.05 will be considered statistically significant.
Hypothesis:
Null: Gabapentin does not attenuate the pressor response. Alternative: Gabapentin attenuates the pressor response.
Rationale:
Gabapentin's potential to modulate sympathetic responses during intubation offers a novel, multimodal approach to anesthesia management. While international studies exist, no local studies have been conducted, making this research vital for assessing its efficacy in the local population.
- Conditions
- Elective Surgical Patients, Blood Pressure
- Being tested
- Gabapentin Group (Group G): Patients will receive 300 mg of oral Gabapentin, Placebo Oral Tablet
- Keywords
- Gabapentin, Laryngoscopy, Hemodynamic Stability, Pressor Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin Group (Group G): Patients will receive 300 mg of oral GabapentinDrug
In this study, the intervention involves administering 300 mg of oral gabapentin to patients in the intervention group two hours prior to surgery, aiming to assess its efficacy in attenuating the pressor response to laryngoscopy and tracheal intubation.
Placebo Oral TabletOther
The placebo group will receive an identical capsule without active medication, administered two hours before surgery, to compare its effects with those of gabapentin on the pressor response to laryngoscopy and tracheal intubation.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin Group (Group G): Participants receiving Gabapentin 300 mg as a pre-treatment. | Experimental | Gabapentin Group (Group G): Participants receiving Gabapentin 300 mg as a pre-treatment. Receives: Drug: Gabapentin Group (Group G): Patients will receive 300 mg of oral Gabapentin |
| Placebo Group (Group P): Participants receiving a placebo as a pre-treatment. | Placebo comparator | Placebo Group (Group P): Participants receiving a placebo as a pre-treatment. Receives: Other: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Pressure (MAP)
The primary outcome is the change in MAP before intubation, 2 minutes, and 5 minutes after laryngoscopy and tracheal intubation. The focus is on whether Gabapentin maintains MAP within 20 mmHg of the patient's baseline reading.
Measured: 2 minutes, and 5 minutes after laryngoscopy and tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion16 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Surgical PatientsStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SYEDA AEMAN ZUBAIR, Liaquat National Hospital & Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705101
- Sponsor's protocol ID
- 0842-2022-LNH-ERC
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GABAPENTIN ATTENUATES THE PRESSOR RESPONSE TO DIRECT LARYNGOSCOPY AND TRACHEAL INTUBATION
- ClinicalTrials.gov ID
- NCT06705101
- Acronym / sponsor ID
- 0842-2022-LNH-ERC
- Conditions
- Elective Surgical Patients, Blood Pressure
- Keywords
- Gabapentin, Laryngoscopy, Hemodynamic Stability, Pressor Response
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 16 Jul 2025 (estimated)
- First posted
- 26 Nov 2024 (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.
This study evaluates the effectiveness of oral gabapentin in reducing the pressor response (increased MAP, HR, and BP) during laryngoscopic intubation. It is a prospective, double-blind randomized controlled trial involving 144 patients undergoing elective surgery. Gabapentin 300 mg or placebo will be administered preoperatively, with hemodynamic parameters monitored before and after intubation. The study aims to determine if gabapentin attenuates the sympathetic stress response compared to placebo.
Detailed description
Laryngoscopic tracheal intubation often triggers a significant sympathetic response, causing increased heart rate, blood pressure, and other hemodynamic changes, which can pose risks for patients with underlying cardiovascular or cerebrovascular conditions. While various methods and drugs have been employed to mitigate this pressor response, gabapentin-a GABA analog with multimodal effects-has shown promise in reducing such hemodynamic stress. This study aims to evaluate the effectiveness of oral gabapentin as a pretreatment to attenuate the sympathetic response during intubation.
The objective of this study is to compare the effectiveness of gabapentin versus placebo in reducing stress responses, such as mean arterial pressure (MAP), heart rate (HR), and blood pressure (BP), during general anesthesia with endotracheal intubation.
Study Design is Prospective, double-blind, randomized controlled trial and will be conducted in Department of Anesthesia, Liaquat National Hospital.
during 8 months. 144 patients (72 per group), calculated based on prior MAP data, with patients randomized into Gabapentin (Group G) and Placebo (Group P) Patients aged 18-59 years, ASA I or II, undergoing elective surgeries will be included.
Exclusion Criteria is difficult intubation, ASA III or higher, obesity, or use of antihypertensive or sedative drugs.
Participants will receive either 300 mg oral gabapentin or placebo 2 hours before surgery. Standard monitoring and anesthesia protocols will be followed, with blood pressure and heart rate recorded at baseline, 2 minutes, and 5 minutes post-intubation. The primary outcome is MAP, while secondary outcomes include systolic/diastolic BP and HR. Intravenous metoprolol will be administered if required for pressor responses.
SPSS v25 will be used for statistical analysis, with independent t-tests for quantitative data and chi-square tests for categorical variables. A p-value <0.05 will be considered statistically significant.
Hypothesis:
Null: Gabapentin does not attenuate the pressor response. Alternative: Gabapentin attenuates the pressor response.
Rationale:
Gabapentin's potential to modulate sympathetic responses during intubation offers a novel, multimodal approach to anesthesia management. While international studies exist, no local studies have been conducted, making this research vital for assessing its efficacy in the local population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin Group (Group G): Participants receiving Gabapentin 300 mg as a pre-treatment. | Experimental | Drug: Gabapentin Group (Group G): Patients will receive 300 mg of oral GabapentinGabapentin Group (Group G): Participants receiving Gabapentin 300 mg as a pre-treatment. |
| Placebo Group (Group P): Participants receiving a placebo as a pre-treatment. | Placebo comparator | Other: Placebo Oral TabletPlacebo Group (Group P): Participants receiving a placebo as a pre-treatment. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I or II patients (American Society of Anesthesiologists Physical Status Classification).
- Age between 18 and 59 years.
- Scheduled for elective surgery under general anesthesia with endotracheal intubation.
Key exclusion criteria (5 listed)
- Anticipated difficult intubation.
- ASA III or greater.
- Patients with hiatus hernia or gastro-esophageal reflux disease (GERD).
- Body weight more than 20% of ideal body weight.
- Patients on antihypertensive drugs, sedatives, hypnotics, or antidepressants.
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 |
|---|---|---|
| Gabapentin Group (Group G): Patients will receive 300 mg of oral GabapentinIn this study, the intervention involves administering 300 mg of oral gabapentin to patients in the intervention group two hours prior to surgery, aiming to assess its efficacy in attenuating the pressor response to laryngoscopy and tracheal intubation. | Drug | Gabapentin Group (Group G): Participants receiving Gabapentin 300 mg as a pre-treatment. |
| Placebo Oral TabletThe placebo group will receive an identical capsule without active medication, administered two hours before surgery, to compare its effects with those of gabapentin on the pressor response to laryngoscopy and tracheal intubation. | Other | Placebo Group (Group P): Participants receiving a placebo as a pre-treatment. |
Primary outcome
Mean Arterial Pressure (MAP)
Time frame: 2 minutes, and 5 minutes after laryngoscopy and tracheal intubation
The primary outcome is the change in MAP before intubation, 2 minutes, and 5 minutes after laryngoscopy and tracheal intubation. The focus is on whether Gabapentin maintains MAP within 20 mmHg of the patient's baseline reading.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- 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.
AEMAN ZUBAIR Dr, FCPS I contact
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gabapentin Group (Group G): Patients will receive 300 mg of oral Gabapentin in people with Elective Surgical Patients and Blood Pressure, run by Liaquat National Hospital & Medical College.
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: opening soon, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AEMAN ZUBAIR Dr, FCPS I (+923332325316), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Pressure (MAP) (time frame: 2 minutes, and 5 minutes after laryngoscopy and tracheal intubation). 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 26 Nov 2024.