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Sedation for gastrointestinal endoscopies in children

Comparison of Propofol-Ketamine combination versus Sevoflurane sedation for gastrointestinal endoscopies in children

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2015/12/006450
Enrollment
60
Registered
2015-12-21
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 for gastrointestinal endoscopies

Interventions

Intervention1: Sevoflurane: Sevoflurane at 4% dial concentration in O2:N2O mixture(50:50) to begin with, followed by mixture of O2 in sevoflurane at 1-2% dial concentration for sedation during gastroi

Sponsors

Vanya Chugh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing elective upper or lower GI endoscopic procedures. American Society of Anaesthesiologists class I & II (I: healthy; II: single, controlled disease state). Parents and guardians of the patient consenting for the procedure.

Exclusion criteria

Exclusion criteria: a. American Society of Anaesthesiologists class III and above. b. Known hypersensitivity to propofol or ketamine or sevoflurane or h/s/o egg allergy. c. Patients with following conditions: i. Airway related problems. ii. Respiratory disorders. iii. Cardiovascular disorders. iv. Central nervous system disorders/neurologic impairment. v. Acute febrile illness. vi. Bleeding oesophageal varices. d. History of recent hepatitis e. Renal insufficiency

Design outcomes

Primary

MeasureTime frame
Time to emergence from procedural sedation Timepoint: 1) Emergence time - From end of procedure till achievement of Modified Ramsay Sedation Score â?¤ 3. 2) Time to respond to light painful stimulus 3) Time to cough 4) Time to spontaneous eye opening 5) Time to achievement of purposeful limb movements 6) Time to child becoming oriented (older children)

Secondary

MeasureTime frame
1) Effectiveness of sedation in terms of Induction time, success of Induction, success of maintenance 2) Safety in terms of occurrence of complicationsTimepoint: â?¢Induction time: Administration of study drugs to fixation of eyeballs, adequate jaw relaxation and Modified Ramsay Sedation Score 4 or 5. â?¢Success of Induction: Induction doses sufficient to allow easy passage of endoscope. Need of changeover from one group to the other will be considered as failure. â?¢Success of maintenance: Maintenance doses sufficient to carry out the procedure. Need of changeover from one group to the other will be considered as failure.

Countries

India

Contacts

Public Contactvanya chugh

Lokmanya Tilak Municipal Medical College and General Hospital

dradmalde@yahoo.com9821085730

Outcome results

None listed

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