Sedation for gastrointestinal endoscopies in children

Active, not recruiting

• Conditions: Paediatric patients for gastrointestinal endoscopies

• Registration Number: CTRI/2015/12/006450
• Lead Sponsor: Vanya Chugh

Brief Summary

*Introduction:*Gastrointestinal(GI) Endoscopy is a well-established procedure done for both diagnostic andtherapeutic purposes. Mild sedation is adequate for adults being subjected toendoscopies but it becomes difficult to obtain cooperation from a childundergoing the same. Multiple studies have been done to develop the ideal method forprocedural sedation in children. Though both propofol-ketamine combinationand sevoflurane have been widely used for procedural sedation, there are notrials comparing the two of them. Hence, this observational study has been plannedto compare the efficacy and safety from intravenous propofol-ketamine withinhalational sevoflurane for procedural sedation in paediatric GI endoscopies.

*Aim:*To evaluate andcompare the efficacy and safety of intravenous propofol-ketamine versus Inhalationalsevoflurane for deep sedation in paediatric GI endoscopic procedures.

*Objectives:*To observefollowing parameters in patients subjected for GI endoscopy under deep sedationwith either intravenous propofol-ketamine or inhalational sevoflurane:

1)   Effectivenessin terms of: Induction time, effectiveness of agents forinduction (insertion of endoscope), effectiveness of agents for maintenance, endoscopist’s comfort with agents used.

2)  Safety:Occurrence of complications like respiratory, haemodynamic fluctuations, needfor restraint, use of additional anaesthetic agents, conversion to trachealtube general anaesthesia

3)   Emergence and recovery: In terms of degree ofsedation, time to recovery,postprocedure agitation score, post procedure nausea vomiting.

*Methodology*:All the patients are premedicated, under controlled environment, in theendoscopy suite with oral Midazolam 0.5 mg/kg dose, 30 minutes prior to entryto the procedure room. In the operating room, patients in IV group receiveKetamine-Propofol (Group KP) 0.5 mg/kg IV ketamine and 1mg/kg IV propofol asloading dose followed by incremental doses of 0.25-0.5mg/kg IV propofol aloneas per the requirement. We will observe for adequacy of loading dose asfixation of eyeballs and adequate jaw relaxation for scope insertion.Patientsin inhalational group receive Sevoflurane (Group S) at 4% dial concentration inO2:N2O mixture(50:50) to begin with. Adequacy of sedationwill be fixation of eyeballs andadequate jaw relaxation for the scope insertion. Sedation is maintained using amixture of O2 in sevoflurane at 1-2% dial concentration withendoscopy mask.

Primary outome measure:  Recovery from sedation

Secondaryoutcome measures: effectiveness of sedation, occurrence of complications.

*Statistical Analysis:* Parametric data will be presented as mean ±standard deviation data and analyzed using unpaired t test. Repeatedmeasurements data will be analyzed using paired t test and binary data will beanalyzed using Chi-squaretest. Nonparametric data will be analyzedusing Mann Whitney U test.

*LacunaIn Existing Knowledge:* Numerousagents have been used for procedural sedation for GI endoscopy. However, thereis lack of consensus regarding the most suitable technique.. Using this study,an attempt is being made to determine an effective and safe technique for GIendoscopic procedural sedation in children.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-04
• Last Update Posted: 2015-04-09

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• 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.
• 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	1) Emergence time - From end of procedure till achievement of Modified Ramsay Sedation Score ≤ 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 Outcome Measures

Name	Time	Method
1) Effectiveness of sedation in terms of Induction time, success of Induction,success of maintenance	2) Safety in terms of occurrence of complications

Trial Locations

Locations (1)

Lokmanya tilak Municipal Medical College and General Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Lokmanya tilak Municipal Medical College and General Hospital

🇮🇳Mumbai, MAHARASHTRA, India

Vanya Chugh

Principal investigator

9999977026

vanya.shibu@gmail.com