COMPARISON OF EFFECTIVENESS AND SAFETY OF ONE ANAESTHETIC DRUG, PROPOFOL ALONE VERSUS PROPOFOL IN COMBINATION WITH ANOTHER ANAESTHETIC AGENT KETAMINE, FOR SEDATION IN CHILDREN FOR GASTROINTESTINAL ENDOSCOPIC PROCEDURES.

A PROSPECTIVE RANDOMIZED COMPARISON OF EFFICACY AND SAFETY OF PROPOFOL VERSUS KETAMINE PLUS PROPOFOL COMBINATION FOR SEDATION IN PAEDIATRIC GASTROINTESTINAL ENDOSCOPIES.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/09/004011

Enrollment

Registered

2013-09-23

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- Paediatric patients with Haematemesis, Ingested foreign bodies, Bleeding per rectum and malnutrition coming for diagnostic and therapeutic GI endoscopy procedures under anaesthesia.

Interventions

Intervention1: Intervention agent: Combination of Injection. Propofol 0.5 mg/kg plus Injection Ketamine 0.5 mg/kg intravenously Comparator agent: Injection Propofol alone 1mg/kg intravenously. : com

Eligibility

Inclusion criteria

Inclusion criteria: a. Pediatric male and female patients between age group 6months - 12 years. b. Patients undergoing elective / outpatient upper GI endoscopic procedures. c. American Society of Anesthesiologists class I & II (I: healthy; II: single, controlled disease state). d. Parents and guardians of the patient consenting for the procedure

Exclusion criteria

Exclusion criteria: a. American Society of Anesthesiologists class III and above. b. Known hypersensitivity to Propofol or h/s/o egg allergy. c. Patients with following conditions which mandate securing of airway with tracheal intubation before the endoscopic procedure: i. Airway related problems. ii. Respiratory disorders. iii. Cardiovascular disorders. iv. Central nervous system disorders/neurologic impairment. v. Acute febrile illness. vi. Actively Bleeding esophageal varices

Design outcomes

Primary

Measure	Time frame
To study efficacy and safety of Intravenous Propofol alone versus Ketamine Plus Propofol combination for sedation in paediatric GI endoscopic procedures: with respect to-Ease of induction, Haemodynamic status, Quality of peri procedural sedation and Time of emergence and recovery And to assess the incidence of complications if any. Timepoint: 0 minutes, every 5 minutes thereafter till the procedure ends, then every 10 minutes for half to one hour after the procedure.	—

Measure

Time frame

To study efficacy and safety of Intravenous Propofol alone versus Ketamine Plus Propofol combination for sedation in paediatric GI endoscopic procedures: with respect to-Ease of induction, Haemodynamic status, Quality of peri procedural sedation and Time of emergence and recovery And to assess the incidence of complications if any. Timepoint: 0 minutes, every 5 minutes thereafter till the procedure ends, then every 10 minutes for half to one hour after the procedure.

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Secondary

Measure	Time frame
Experience with the Endoscopy mask for both upper and lower Gi endoscopic proceduresTimepoint: At the end of the procure.	—

Countries

India

Contacts

Public ContactDr Smita Madhusudan Gaikwad

Lokmanya Tilak Municipal Medical College and General Hospital, Sion

dradmalde@yahoo.com09821085730

Outcome results

None listed

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