Comparing two drug combinations for sedation and pain relief for bone biopsy under CT-scan.

Not yet recruiting

• Conditions: Disseminated malignant neoplasm, unspecified,

• Registration Number: CTRI/2019/11/022038
• Lead Sponsor: Dr Shagun Bhatia Shah

Brief Summary

This study is a prospective, interventional, double blind, randomised, parallel arm, active controlled, single centric study comparing two anaesthetic drug combinations for providing sedation and analgesia in 60 adult patients of either sex undergoing either CT-guided core biopsy or radiofrequency ablation in metastatic cancer patients.The patients shall be randomly allocated to either Group K( Ketamine+ Dexmedetomidine) or Group F(Fentanyl + Dexmedetomidine). All patients shall be premedicated with midazolam ( 0.03mg/kg) and shall receive dexmedetomidine infusion(1mg/kg loading dose over 10 minutes followed by 0.5mg/kg maintenance infusion). Dexmedetomidine is expected to neutralize the tachycardia, hypertension and salivary secretions and hallucinations produced by ketamine whereas ketamine is expected to neutralize the bradycardia , hypotension and dry mouth due to ketamine. Hence this combination i expected to provide maximal analgesia with minimum complications and may prove to be the ideal combination for procedural sedation. The primary outcome measures would be the heart rate , mean arterial pressure, response to pain, respiratory rate and arterial oxygen saturation at various time points( Baseline; After dexmedetomidine loading dose; 1 minute after ketamine/fentanyl bolus; on Biopsy; After 10 minutes of procedure; After 20 minutes of procedure; After 30 minutes of procedure; After 40 minutes of procedure; After 50 minutes of procedure; At the end of procedure). The secondary outcome measures would be the post-operative visual analog score (VAS) at rest and on coughing, postoperative nausea/ vomiting(PONV), orientation of the patient and Aldrete score at the end of the procedure.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-11-15
• Study Start: 2019-11-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

ASA I- II patients Weight 40-80 kg Either Sex Undergoing CT-guided core biopsy/RFA.

Exclusion Criteria

Patients with raised intracranial tension Pre-existing psychiatric disorder Opioid dependence Geriatric age group(Age>60 yrs) Bradycardia (Heart Rate< 60/min).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart rate; Mean Arterial Pressure;Pain response;Respiratory rate;Arterial Oxygen Saturation	0 min(Baseline);10mins (After dexmedetomidine loading dose),14mins (1 minute post ketamine/ fentanyl boluses);15 mins (At Biopsy);25 mins (After 10 minutes of procedure);35 mins (After 20 minutes of procedure); 45 mins (After 30 minutes of procedure); 55 mins (After 40 minutes of procedure);65 mins (After 50 minutes of procedure);75 mins (At end of procedure)

Secondary Outcome Measures

Name	Time	Method
Visual Analog Score(VAS)at rest;Visual Analog Score(VAS)on coughing;	Post-Operative nausea/Vomiting(PONV);

Trial Locations

Locations (1)

Rajiv Gandhi Cancer Institute and Research Centre; 🇮🇳 West, DELHI, India

Rajiv Gandhi Cancer Institute and Research Centre

🇮🇳West, DELHI, India

Dr Shagun Bhatia Shah

Principal investigator

9891769779

shah.shagun@rgcirc.org