Intravenous Rabeprazole in prevention of pulmonary acid aspiration during surgery in patients under general anesthesia
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2019/08/020733
- Lead Sponsor
- D Y Patil University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gastric pH (fluid aspirate from nasogastric tube)Timepoint: 90-120 minutes after injection
- Secondary Outcome Measures
Name Time Method Volume of gastric contents (fluid aspirate from nasogastric tube)Timepoint: 90-120 minutes after injection