comparison of two sedation technique in children with congenital heart disease.

Phase 3

Completed

• Conditions: Imaging,

• Registration Number: CTRI/2023/11/059539
• Lead Sponsor: Post Graduate Institute of Medical Education ResearchChandigarh

Brief Summary

For the study, two groups of patients will be taken. After a thorough pre-anaesthetic evaluation, confirming fasting status and obtaining parental consent, baseline vitals (HR, Oxygen saturation) will be recorded. Patients will be randomly allocated to one of two groups using computer-generated random numbers. Preoperative anxiety will be scored at 2 time points – in the preoperative holding area and at the time of administration off sedative, using the modified Yale Preoperative Anxiety Scale (mYPAS)16. Following this Group A children will be given a combination of midazolam 0.05 mg/kg, glycopyrrolate 0.01 mg/kg and ketamine 0.5 mg/kg iv in the mother’s lap inside the CT suite. Ketamine will be titrated every 30 seconds in steps of 0.25 mg/kg to achieve a Paediatric Sedation State Scale (PSSS) of 2. Group B children will also be given the same combination but after shifting the child inside the CT suite on the CT table. A maximum cumulative dose of 2 mg/kg of ketamine will be used during induction of sedation. If the child fails to achieve an PSSS of 2 at this maximum dose, the child will be excluded from the study and alternative sedatives will be used at the treating clinician’s discretion.

The total requirement of ketamine required for keeping the child sedated (PSSS of 2) child during the whole procedure will be recorded. If the child moves during the procedure or is agitated, it will be noted and an additional bolus of 0.25 mg/kg of ketamine will be given to achieve an PSSS of 2 in both the groups. The amount of bolus/number of boluses required will be recorded. Any episodes of desaturation (10% from baseline), cyanosis and apnea will be noted. After the procedure, the child will be shifted to the recovery room with oxygen and the time required to awaken the child will be noted.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-15
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

child with diagnosed complex cyanotic congenital heart disease (ASA III or IV) with baseline saturation less than 90 per cent requiring sedation for cardiac CT angiography.

Exclusion Criteria

• Acyanotic CHD 2.
• Older children >3 years 3.
• refusal of consent by parents 4.
• Active URI 5.
• Contraindication for contrast (CKD) 6.
• Contrast allergy 7.
• Full stomach children.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To quantify the difference in dose of ketamine required to achieve a Pediatric Sedation State	From the onset of the sedation process till the achievement of PSSS 2. up to 30 minutes.
Scale of 2 between the two techniques (lap vs table).	From the onset of the sedation process till the achievement of PSSS 2. up to 30 minutes.

Secondary Outcome Measures

Name	Time	Method
1. To record any episodes of desaturation and bradycardia (reversal of shunt).	2. To record the total amount of ketamine required during the whole procedure.

Trial Locations

Locations (1)

Advanced Pediatric Centre, Post Graduate Institute of Medical Education & Research, Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

Advanced Pediatric Centre, Post Graduate Institute of Medical Education & Research, Chandigarh

🇮🇳Chandigarh, CHANDIGARH, India

Dr Ajay Singh

Principal investigator

09999276845

ajay.ydv2509@gmail.com