Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Injection Clonidine 2 microgram per kg body weight dissolved in 50 mL normal saline: Injection Clonidine 2 microgram per kg body weight dissolved in 50 mL normal saline given as intrave
Sponsors
MPMMCC Mahamana Pandit Madan Mohan Malviya Cancer Centre Tata Memorial Centre Varanasi
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria Age 18 to 70 years (both inclusive) ASA I / II Elective head and neck surgery with primary tumor resection Written informed consent
Exclusion criteria
Exclusion criteria: Exclusion Criteria Preoperative HR less than 55 bpm Preoperative MAP less than 65 mmHg More than 1st degree AV block on preoperative preoperative ECG Recent myocardial infarction (less than 3 months) Recent stroke (less than 3 months) Chronic clonidine therapy Patient received any beta blocker (metoprolol, propranolol, bisoprolol, nebivolol, atenolol, etc) within the last 7 days Patient received verapamil or diltiazem within the last 7 days Known allergy to clonidine Pregnancy Emergency surgery Re-operation Surgery involving only neck dissection Surgery involving only head and neck reconstructive surgery Diagnosed chronic heart failure, NYHA Functional Class II or above, as documented in the pre-operative record or echocardiographic report within the preceding 3 months. Acute decompensated heart failure at the time of pre-anaesthetic assessment, irrespective of aetiology or NYHA class. Current use of Ivabradine, defined as Ivabradine administered within 7 days prior to the scheduled surgery date. (Screening - Ivabradine use will be identified from medication history and the PAC drug reconciliation record. CHF/AHF status will be identified from case records, PAC assessment, and available echocardiography reports.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemodynamic Stability Index, defined as the percentage of intraoperative 3 minute interval time points during the primary tumor resection period at which both heart rate and mean arterial pressure remain within 20 percent of baseline. Assessment period is from commencement of the study drug or placebo infusion to completion of primary tumor resection as declared by the operating surgeon.Timepoint: Baseline, and every 3 minutes intraoperatively from commencement of study drug or placebo infusion until completion of primary tumor resection. The final HSI will be calculated immediately after completion of primary tumor resection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak MAP at tumor resection Peak HR at tumor resection Total opioid dose Incidence of unstable bradycardia Total vasopressor requirement Postoperative ventilation in first 24h Postoperative nausea and vomiting Severe hypertension in first 24hTimepoint: During tumor resection Within first 24h | — |
Countries
India
Contacts
Public ContactDr Jyotirmay Kirtania
MPMMCC (Mahamana Pandit Madan Mohan Malviya Cancer Centre) Tata Memorial Centre Varanasi
Outcome results
None listed