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Effect of a drug called dexmeditomiodine for comfort and satisfaction of patient for endoscopy procedure

Nebulized dexmedetomidine for patients comfort and satisfaction during esophagogastroduodenoscopy-A double blind randomised controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034447
Enrollment
110
Registered
2021-06-29
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: K263- Acute duodenal ulcer without hemorrhage or perforation Health Condition 2: K20-K31- Diseases of esophagus, stomach and duodenum

Interventions

Intervention1: nebulised dexmedetomidine in esophagogastroduodenoscopy: dexmedetomidine 1�µg/kg diluted in normal saline (0.9%) to make a volume of 5 ml nebulised to patients undergoing esophagogasr

Sponsors

IMS and SUM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA-1, 2, age 18 years to 65 years Elective esophagogastroduodenoscopy

Exclusion criteria

Exclusion criteria: a therapeutic EGD, ASA- Class 3 or higher, uncontrolled hypertension, seizure disorders, patient on anti-depressants/anti-psychotics, patients with a poor cardiopulmonary reserve and with body mass index (BMI) >30 kg/m2, renal failure, decompensated cirrhosis, age less than 18 years or more than 65 years, being pregnant, or refusal to provide written informed consent

Design outcomes

Primary

MeasureTime frame
The primary outcome was the patientââ?¬â?¢s self-reported discomfort scores during esophageal intubation, assessed with a 0ââ?¬â??10 (0 - none; 10 - unbearable) visual analog scale. Timepoint: Baseline, and after 10 minutes

Secondary

MeasureTime frame
discomfort score during the procedure and overall satisfaction with the procedure (0 - not satisfied at all; 10 - very satisfied) as evaluated by the patients; patient tolerance to the procedure, ease of intubation of the endoscope, and satisfaction with the procedure as evaluated by the endoscopists; and number of coughing and retching episodesTimepoint: time is during the procedure till completion of esophagogastroduodenoscopy

Countries

India

Contacts

Public ContactDr Bhavna Sriramka

IMS and sum hospital

bhavna.sriramka@gmail.com7751007807

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 8, 2026