A clinical trial to study two drugs dexmedetomedine and ketamine in small doses in removing procedural discomfort during spinal anaesthesia

Completed

• Conditions: American society of anaesthesiologists class 1

• Registration Number: CTRI/2015/06/005888
• Lead Sponsor: Mahatma Gandhi medical college and research institute

Brief Summary

Subanaesthetic doses of  Ketamine has been tried for procedural sedation in the past.1, 2 Dexmedetomidine is increasingly used as a sedative drug for procedural sedation in various surgeries in recent times.3.4 There are no studies in literature comparing ketamine and dexmedetomedine  for allaying procedural discomfort. So we would like to compare the efficacy of dexmeditomedine and  subanaesthetic dose of ketamine in allaying procedural discomfort during establishment of subarachnoid block

  Aims and objectives; To compare the efficacy of dexmeditomedine and  subanaesthetic dose of ketamine in allaying procedural discomfort during establishment of subarachnoid block with regard to 1. Degree of sedation, 2. Ease of positioning, 3. Prick response 3. Time interval between study drug injection and response to verbal commands 4. Complications 5. Recall of procedure, 6. Patient satisfaction

hypothesis: **dexmeditomedine is better than  subanaesthetic dose of ketamine in allaying procedural discomfort during establishment of subarachnoid block**

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-07
• Last Update Posted: 2015-04-06

Recruitment & Eligibility

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

Inclusion Criteria

• Willingness.
• ASA 1 & 2 physical status.
• Age 18 to 50 years.

Exclusion Criteria

• Allergic to drugs used.
• Psychiatric disorder.
• Patients on beta blocker therapy.
• Contraindicated to SAB.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Degree of sedation	1. during subarachnoid block look for prick response | 2. level of sedation while patient is positioned for subarachnoid block | 3. recall of spinal procedure at the end of surgery | 4. verbal response time after sedation | 5. satisfaction at the end of surgery | 6. ease of positioning after Subarachnoid block
2. Ease of positioning	1. during subarachnoid block look for prick response | 2. level of sedation while patient is positioned for subarachnoid block | 3. recall of spinal procedure at the end of surgery | 4. verbal response time after sedation | 5. satisfaction at the end of surgery | 6. ease of positioning after Subarachnoid block
3. Prick response	1. during subarachnoid block look for prick response | 2. level of sedation while patient is positioned for subarachnoid block | 3. recall of spinal procedure at the end of surgery | 4. verbal response time after sedation | 5. satisfaction at the end of surgery | 6. ease of positioning after Subarachnoid block
4.Time interval between study drug injection and response to verbal commands	1. during subarachnoid block look for prick response | 2. level of sedation while patient is positioned for subarachnoid block | 3. recall of spinal procedure at the end of surgery | 4. verbal response time after sedation | 5. satisfaction at the end of surgery | 6. ease of positioning after Subarachnoid block
5. Recall of procedure	1. during subarachnoid block look for prick response | 2. level of sedation while patient is positioned for subarachnoid block | 3. recall of spinal procedure at the end of surgery | 4. verbal response time after sedation | 5. satisfaction at the end of surgery | 6. ease of positioning after Subarachnoid block
6. Patient satisfaction	1. during subarachnoid block look for prick response | 2. level of sedation while patient is positioned for subarachnoid block | 3. recall of spinal procedure at the end of surgery | 4. verbal response time after sedation | 5. satisfaction at the end of surgery | 6. ease of positioning after Subarachnoid block

Secondary Outcome Measures

Name	Time	Method
1. complications	2. hemodynamic variation from drug administraion to patient positioning after subarachnoid block

Trial Locations

Locations (1)

Mahatma Gandhi Medical College and Research Institute; 🇮🇳 Pondicherry, PONDICHERRY, India

Mahatma Gandhi Medical College and Research Institute

🇮🇳Pondicherry, PONDICHERRY, India

Hemanth Kumar VR

Principal investigator

9003550553

drvrhk@gmail.com