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To compare the effect of oral Gabapentin and Pregabalin drug on intubation and abdominal carbon dioxide insuffalation response in patients undergoing laparoscopic gall bladder surgery.

A Comparison of Oral Gabapentin and Pregabalin Premedication for Attenuation of Hemodynamic Responses to Endotracheal Intubation and Pneumoperitoneum in Laparoscopic Cholecystectomy.

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012428
Enrollment
90
Registered
2018-03-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- ASA grade 1 and 2. Health Condition 2: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: oral premedication.: Group B: Patients received Gabapentin 800 mg in the form of two capsules containing 400 mg of Gabapentin, each orally with sips of water as premedication 2 hours pr

Sponsors

Bhupinder Singh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) ASA Grade I & II adult patients. 2) Patients aged 18 to 60 yrs. 3) Patients undergoing elective laparoscopic cholecystectomy under general anaesthesia.

Exclusion criteria

Exclusion criteria: 1. Patient with anticipated difficult intubation. 2. Patient with ASA III or greater. 3. Patient with cardiac, pulmonary or renal disease. 4. Patient with obesity (BMI >30) 5. Patient who are sensitive to any drugs involved in the study. 6. Patient who are on antihypertensives, sedatives, hypnotics. 7. Patient who require second attempt for intubation. 8. Patient who require duration of laryngoscopy exceeding 20 sec. 9. Pregnant and lactating women. 10. Patients who require intubation other than orotracheal.

Design outcomes

Primary

MeasureTime frame
To study and compare attenuation of hemodynamic responses to laryngoscopy and pneumoperitoneum during laparoscopy between oral Gabapentin and oral Pregabalin.Timepoint: I) Heart rate, Non invasive systolic, diastolic, mean arterial blood pressure, were recorded firstly at baseline (before premedication), before induction (after premedication on coming to operation theatre after 2hrs), just after laryngoscopy and intubation, and at T0, T1, T3, T5 and T10 minutes. Secondly, before pneumo peritoneum, just after pneumo peritoneum atT0, T5, T10, T15 and T30 minutes and after the release of pneumoperitoneum at T0, T5, T10 and T15 minutes.

Secondary

MeasureTime frame
Observation of any adverse effects due to oral Gabapentin 800mg and oral Pregabalin 150mg.Timepoint: Post operative adverse effects such as nausea and vomiting, respiratory depression, dizziness, somnolence, blurred vision, headache, pruritis, peripheral oedema and diplopia were noticed; upto 6 hours in post operative period. ;Recovery charaterstics of patients.Timepoint: Recovery charaterstics of patients were recorded till 4hours in post operative period using modified alderete scoring system.;To study and compare preoperative and postoperative sedation level of oral Gabapentin 800mg and of oral Pregabalin150mg. Timepoint: Level of sedation of the patients was monitored every 30 minutes, 1½ hours prior to surgery using Ramsay sedation scale and post operatively every 15 min for 2 hours and every 30 min for next 4 hrs.

Countries

India

Contacts

Public ContactDr Bhupinder Singh

Satguru Partap Singh Hospitals

Drritulmehta@yahoo.co.in9872260704

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026