A clinical trial to study the effect of a drug dexmedetomidine as adjuvant to local anaesthetic drug ropivacaine using ultrasound guided fascial plne block named erector spinae plane block in patients posted for cardiac surgery
Phase 3
- Conditions
- Health Condition 1: I998- Other disorder of circulatory system
- Registration Number
- CTRI/2023/07/055501
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Inclusion criteria will be adult cardiac surgical patients aged 18 to 65 years undergoing elective cardiac surgery.
Exclusion Criteria
Exclusion criteria will be as follows:
1.Patient refusal
2.Deranged coagulation profile
3.Spine deformity
4.Local skin infection
5.Baseline HR <60 BPM
6.Hepatic or renal insufficiency
7.Significant left main disease
8.Severe LV systolic dysfunction (LVEF <30%)
9.Patients weighing <40kg and >70kg
10.Hemodynamically unstable patient
11.Patients requiring >24 hrs mechanical ventilation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PRIMARY OUTCOME: Total fentanyl consumption (intraoperative & postoperative) in 24 hrs.Timepoint: PRIMARY OUTCOME: Total fentanyl consumption (intraoperative & postoperative) in 24 hrs.
- Secondary Outcome Measures
Name Time Method SECONDARY OUTCOME: <br/ ><br>1.Duration of postoperative pain relief defined as time in minutes to first rescue analgesia (1mic/Kg fentanyl) when VAS 4 or patient demands analgesia. <br/ ><br>2.Incidence of Operating room extubation <br/ ><br>3.Change in mechanical ventilation duration <br/ ><br>4.Changes in VAS at every 6hrly till 24 hours since administration of block. <br/ ><br>5.Incidence of adverse events: Hypotension & bradycardia <br/ ><br>Timepoint: for 24 hrs