A clinical trial on comparison of Ketamine-Propofol combination with or without Fentanyl for sedation in children undergoing surgeries below the umbilicus under spinal anaesthesia

Comparison of Ketamine-Propofol combination with or without Fentanyl for sedation in children undergoing infraumbilical surgeries under spinal anaesthesia

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/03/012590

Enrollment

Registered

2018-03-15

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- AGE 3-8 YEARS ASA GRADE I AND II

Interventions

Intervention1: KETAMINE PROPOFOL FENTANYL GROUP(KPF): EMLA cream will be applied at the potential site of intravenous cannulation and skin puncture site for spinal anaesthesia to both the groups 45 mi

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 3 â??8 years belonging to American Society of Anaesthesiologists (ASA) grade I & II undergoing infraumbilical surgery with tentative duration of surgery <= 90 minutes.

Exclusion criteria

Exclusion criteria: Any contraindications for neuraxial blockade- spinal deformities, local site infection, known case of coagulopathy, raised ICP etc. Known allergy to local anaesthetic agents, propofol. Patients with systemic disease, neurological impairment, airway abnormality, Intercurrent URTI

Design outcomes

Primary

Measure	Time frame
To assess intraoperative pediatric sedation state scale and postoperative Modified aldrete score using ketamine and propofol combination with or without fentanyl for sedation in these children.Timepoint: intra operative period and post operative period	—

Secondary

Measure	Time frame
To assess intraoperative and postoperative haemodynamic and respiratory parameters using ketamine and propofol combination with or without fentanyl for sedation in these children.Timepoint: INTRAOPERATIVE AND POST OPERATIVE PERIOD	—

Countries

India

Contacts

Public ContactDr Rohini Dubey

VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL

amitaguptadr@gmail.com9910382190

Outcome results

None listed

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