Sedation for gastrointestinal endoscopies in childre
Not Applicable
- Conditions
- Health Condition 1: null- Paediatric patients for gastrointestinal endoscopies
- Registration Number
- CTRI/2015/12/006450
- Lead Sponsor
- Vanya Chugh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to emergence from procedural sedation <br/ ><br>Timepoint: 1) Emergence time - From end of procedure till achievement of Modified Ramsay Sedation Score â?¤ 3. <br/ ><br>2) Time to respond to light painful stimulus <br/ ><br>3) Time to cough <br/ ><br>4) Time to spontaneous eye opening <br/ ><br>5) Time to achievement of purposeful limb movements <br/ ><br>6) Time to child becoming oriented (older children) <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1) Effectiveness of sedation in terms of Induction time, success of Induction,success of maintenance <br/ ><br>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. <br/ ><br>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. <br/ ><br>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. <br/ ><br>