Strategic preoperative fentanyl administration before general anaesthesia for holistic perioperative analgesia

Recruiting

Conditions: perioperative pain during laparoscopic surgery

Registration Number: CTRI/2012/01/002391

Lead Sponsor: Department of Anaesthesiology Pain and Perioperative Medicine

Brief Summary: Opioids are routinely administered during the pre-induction period of general anaesthesia (GA) process. Fentanyl, a synthetic opioid, is most commonly employed opioid agent owing to its analgesic potency, ease of administration and lack of significant side effects at routine intravenous doses (2-10 mg/kg). The analgesic use of fentanyl is random and at the best scattered over the perioperative espanse of GA. Surprisingly, the pre-emptive effect of fentanyl as a sole analgesic has not been studied. Primarily, it is preferably, used as a reactive analgesic agent to contain subjective pain sensation the patient expresses postoperatively. In addition, the use of fentanyl is more often than not inadequate owing to fear among anesthesia physician of its side effects including over-sedation, respiratory depression, postoperative nausea and vomiting (PONV), cough and chest wall rigidity.

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This research aims to use fentanyl during the pre-induction period with a proactive strategy to gain pre-emptive analgesia, objective attainment of â€˜balanced anesthesiaâ€™ end points, stable hemodynamics and avoidance of its common side effects. The phased pattern of research is expected to add to the evolution of a new concept, i.e. â€˜perioperative analgesiaâ€™, which will positively impact overall post surgical patient outcome.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 300

Inclusion Criteria

1.Male or female gender 2.Aged 20-70 years 3.Scheduled surgery: Laparoscopic surgery (30-minutes to 150- minutes) 4.General anaesthesia 5.Elective nature of intervention 6.Consenting for surgery.

Exclusion Criteria

Patients with uncompensated systemic co-morbidity [cardiac (hypertension, coronary artery disease, cardiomyopathy, arrhythmias), respiratory (bronchial asthma, COPD), endocrinology (diabetes mellitus, thyroid disease), hepato-renal, CNS 2.
Allergy to opioid drugs 3.
History of substance abuse 4.
Psychiatric illness 5.
Any previous history of respiratory depression with opioids.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.The impact of three equi-dose pre-induction IV fentanyl dosing strategy on indices related to prevailing â€˜balanced anaesthesiaâ€™ concept.	From first dose of fentanyl to 48 hrs time point
2.Analysis of best pre-induction fentanyl dosing strategy in terms of balanced anaesthesia, postoperative analgesia and side-effects reduction.	From first dose of fentanyl to 48 hrs time point

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Department of Anesthesiology , Pain and Perioperative Medicine Sir Ganga Ram Hospital
🇮🇳
Delhi, DELHI, India
Department of Anesthesiology , Pain and Perioperative Medicine Sir Ganga Ram Hospital
🇮🇳Delhi, DELHI, India
Dr Amitabh Dutta
Principal investigator
01142252513
duttaamitabh@yahoo.co.in