Introduction: Gastrointestinal (GI) Endoscopy is a well-established procedure done for both diagnostic and therapeutic purposes. Mild sedation is adequate for adults being subjected to endoscopies but it becomes difficult to obtain cooperation from a child undergoing the same. Multiple studies have been done to develop the ideal method for procedural sedation in children. Though both propofol-ketamine combination and sevoflurane have been widely used for procedural sedation, there are no trials comparing the two of them. Hence, this observational study has been planned to compare the efficacy and safety from intravenous propofol-ketamine with inhalational sevoflurane for procedural sedation in paediatric GI endoscopies.

Aim: To evaluate and compare the efficacy and safety of intravenous propofol-ketamine versus Inhalational sevoflurane for deep sedation in paediatric GI endoscopic procedures.

Objectives: To observe following parameters in patients subjected for GI endoscopy under deep sedation with either intravenous propofol-ketamine or inhalational sevoflurane:

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

2)  Safety: Occurrence of complications like respiratory, haemodynamic fluctuations, need for restraint, use of additional anaesthetic agents, conversion to tracheal tube general anaesthesia

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

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

Primary outome measure:  Recovery from sedation

Secondary outcome 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. Repeated measurements data will be analyzed using paired t test and binary data will be analyzed using Chi-square test. Nonparametric data will be analyzed using Mann Whitney U test.

Lacuna In Existing Knowledge: Numerous agents have been used for procedural sedation for GI endoscopy. However, there is lack of consensus regarding the most suitable technique.. Using this study, an attempt is being made to determine an effective and safe technique for GI endoscopic procedural sedation in children.