FindTrial
Sign In

The impact of preinduction fentanyl dosing strategy on postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: A concept evaluation of equi-dose fentanyl given as a single-bolus or divided intermittent boluses or continuous infusion administration technique.

The impact of preinduction fentanyl dosing strategy on postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy: A concept evaluation of equi-dose fentanyl given as a single-bolus or divided intermittent boluses or continuous infusion administration technique.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21891
Enrollment
270
Registered
2011-02-19
Start date
2011-03-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post operative nausea & vomiting (PONV) in patients undergoing laparoscopic cholecystectomy. Keywords- Post operative nausea & vomiting (PONV) , laparoscopic cholecystectomy Trefwoorden-Post-operatieve misselijkheid en braken (PONV), laparoscopische cholecystectomie

Interventions

All the patients scheduled for laparoscopic cholecystectomy under general anaesthesia will be randomly (simple computer generated random number table) allocated to one of the following three groups:
Group.II: Intermittent 1µg/kg fentanyl IV (total-3µg/kg) given thrice during the pre-induction period (3 minutes apart
i.e., 0, 3, 6 minutes)
Group.III: Continuous intravenous infusion of 3µg/kg fentanyl over 6 minutes prior to induction. Patients will be extubated once wide-awake. Any regurgitation during the peri-extubation period will b

Sponsors

Department of Anaesthesiology, Pain and Perioperative Medicine. Sir Ganga Ram Hospital, Old Rajinder Nagar ,New Delhi-110060 .India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female gender; 2. Aged 20-60 years age; 3. Scheduled surgery: Laparoscopic cholecystectomy; 4. General anaesthesia; 5. Elective nature of intervention; 6. Consenting for surgery; 7. ASA physical status I-II.

Exclusion criteria

Exclusion criteria: 1. 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. Acute nature of gall bladder pathology (cholecystitis); 6. Those with a tendency/recent history of hyperemesis; 7. H/o postoperative emesis.

Design outcomes

Primary

MeasureTime frame
1. The impact of pre-induction IV fentanyl dosing methodology on reduction of PONV incidence; 2. Reduction in the use of postoperative antiemetics.—

Secondary

MeasureTime frame
The effect of different methods of pre-induction intravenous fentanyl administration method on patient response profile including: 1. Hemodynamics: Heart rate (HR), noninvasive blood pressure (NIBP); 2. Respiration: Respiratory rate (RR), depth of breathing, oxygen saturation (SpO2); 3. Central nervous system: Orientation, consciousness (level of sedation), bispectral index (BIS).—

Contacts

Public ContactNitin Sethi

Dept of Anaesthesiology, Pain & Perioperative Medicine Sir Ganga Ram Hospital, Old Rajinder Nagar

nitinsethi77@yahoo.co.in

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)