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Intravenous Rabeprazole in prevention of pulmonary acid aspiration during surgery in patients under general anesthesia

A randomized, double-blind, placebo-control, multicenter, clinical trial to evaluate the efficacy and safety of intravenous (IV) Rabeprazole in prevention of pulmonary acid aspiration during surgery in patient under general anesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020733
Enrollment
60
Registered
2019-08-16
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Injection Rabeprazole 20 mg: IV Rabeprazole 20 mg injected along with preanesthetic medication Control Intervention1: None: Patients will receive only Pre-anaesthetic medication as per

Sponsors

D Y Patil University School of Medicine
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who will be undergoing elective surgery under general anesthesia 2. Patients who will require endotracheal intubation. 3. American Society of Anesthesiologists (ASA) physical status I (a normal healthy patient) and class-II (a patient with mild systemic disease). 4. Female patients must have a negative urine pregnancy test at screening. 5. Patient capable of understanding, providing written informed consent and follow study related procedures.

Exclusion criteria

Exclusion criteria: 1. Patient with known hypersensitivity and contraindication to Rabeprazole, or any study treatment. 2. Obese patients who will be >20% heavier than their ideal body weight &/or body mass index (BMI) more than 40 kg/m2. 3. Patients taking medication known to affect gastric fluid composition or gastric emptying. 4. Patients with any upper gastrointestinal disorders. 5. Patient receiving medications known to affect the secretory and/or motor functions of the stomach. 6. Mallampati class IV (soft palate not visible at all) and/or mouth opening less than 5 cm and/or thyromental distance less than 6.5 cm. 7. Patients with contraindication to orogastric/nasogastric tube placement. 8. Patients with history of difficult intubation, intestinal obstruction, parturients, diabetes mellitus. 9. IV &/oral administration of PPI within 24 hour before randomization. 10. Patient with suspicion of gastric malignancy. 11. Patient with Zollinger-Ellison syndrome. 12. Patient taking a drug known to interact with PPIs (phenytoin, clarithromycin, itraconazole, ketoconazole, warfarin, cyclosporine and other vitamin K antagonists, cisapride, atazanavir, or ritonavir) within 24 hour before enrollment.

Design outcomes

Primary

MeasureTime frame
Gastric pH (fluid aspirate from nasogastric tube)Timepoint: 90-120 minutes after injection

Secondary

MeasureTime frame
Volume of gastric contents (fluid aspirate from nasogastric tube)Timepoint: 90-120 minutes after injection

Countries

India

Contacts

Public ContactDeepakkumar Langade

D Y Patil University School of Medicine and Hospital

deepak.langade@dypatil.edu9930550009

Outcome results

None listed

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