Post operative pain comparison in patients undergoing elective laparoscopic surgery who is receving fentanyl and the patients who is receiving dexmedetomidine

Not yet recruiting

• Registration Number: CTRI/2021/01/030301
• Lead Sponsor: JSS MEDICAL COLLEGE AND HOSPITAL

Brief Summary

Following approval from institutional ethicalcommittee, informed consent and written consent will be taken from 70 patientsof American Society of Anaesthesiologist (ASA) physical status class I/IIundergoing laparoscopic surgeries under general anaesthesia.

Patients will berandomly allocated into 2 groups;

Group 1- DK group

ReceivingDexmedetomidine 1mcg/kg/body weight& ketamine 25mg intravenously.

Group 2- F group

Receiving Fentanyl1mcg/kg/body weight intravenously.

Randomization will be done by anotheranaesthesiologist (who will not take part further in the study) using shuffledsealed envelope technique.

All the patients are evaluated on the previous day ofsurgery& on the morning of the surgery. Patients are shifted to operationtheatre and connected with multi parameter monitor (PHILIPS intellivue MP-20)and baseline parameters like systolic blood pressure(SBP); diastolic bloodpressure (DBP);mean arterial pressure(MAP) &heart rate (HR), saturation ofO2 will be noted.

Patients belonging to DK group will receive Inj Dexmeditomidine 1mcg/kg diluted to100ml NS and infused over 10-15min beforeinduction. Inj. Ketamine 25mg diluted to 2ml with NS will be injected beforeinduction.

Patientsbelongs to F group will receive 100 ml of NS over 10-15 min before inductionand Inj Fentanyl 1mcg/kg diluted to 2 ml will be administrated iv beforeinduction.

The studydrugs will be prepared by the same anaesthesiologist involved with randomizationwho will not take part further in the study and thus the observer and patientwill be blinded to study.

All thepatients will be given 1.5mg/kg/body weight of IV lidocaine(preservative free)after pre-oxygenation for 3min, followed by 1% propofol till the loss of eyelash reflexes and total dose of propofol used will be noted.

All the patients will be intubated with appropriatesized ET tubes using 0.1mg/kg of vecuronium. Patients will be maintained usingO2+N2O(30:70) and isoflurane 0.5%. Intraoperative blood pressure (BP) and heart rate (HR)will be monitored and any increase of either BP or HR more than 20% of baselinewill be managed by increasing the isoflurane to 1% and if not controlledadditional boluses of 20mg of propofol will be given and number of doses ofpropofol will be noted. Any fall in SBP more than 30% will be treated with IVfluids and if required 6mg of ephedrine boluses & number of doses ofephedrine will be noted. Any decrease in heart rate less than 50/min will betreated with Inj. Atropine 0.6mg. Patients will be given Inj. Dexamethasone 8mgafter induction and Inj. Ondansetron 4mg just before extubation. Patients areadministered with inj. Paracetamol 1gm IV and Inj. Diclofenac 75mg ivintraoperatively. At end of surgery patients will be reversed with 0.05mg/kg Inj  Neostigmine and Inj Glycopyrolate 0.01mg/kg.

Time ofrecovery will be noted from the time of administrating reversal drugs andpatients satisfying the extubation criteria are extubated. All the patients areshifted to post anaesthetic care unit (PACU) and monitored for post-operativepain using VAS score at the interval of immediate post- operative and 2nd  hourly for 6 hours and every 6th hourly for 24 hours. Any patient with VASscore >4 will receive rescue analgesic Inj. Diclofenac 75mg and number ofdoses in 24 hours will be noted.

Incidenceof post-operative nausea and vomiting will be noted every 2nd hourly up to 6 hours and every 6th hourly up to 24 hours. Incidence ofpost-operative nausea and vomiting (PONV) will be treated with Inj. Ondansetron4mg and the number of injections will be noted.

Thepost-operative sedation will be noted based on Ramsay sedation scoreimmediately after extubation.

Ramsay sedationscore:

**Score         Definition**

1Anxious and restless oragitated or both**.**

2              Co-operative, oriented andtranquil.

3              Responds to commands only.

4              Brisk response to a lightglabellar tap or loud auditory stimulus.

5              Slight response to a lightglabellar tap or loud auditory stimulus.

6              No response to a light glabellartap or loud auditory stimulus.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-06-01
• Study Start: 2021-07-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Patients of ASA physical status class 1 and 2 aged 20-60 years undergoing elective laparoscopic surgeries lasting for <2 hours.

Exclusion Criteria

Pregnant, breast feeding women, hepatic, renal or cardiac insufficiency, psychiatric disease, allergy or contraindicated to study drugs, BMI >30, Obstructive sleep apnoea syndrome.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of post-operative pain intensity in terms of visual analogue score (VAS) and rescue analgesics requirements	starting of general anaesthesia till twenty four hours after completion of surgery.

Secondary Outcome Measures

Name	Time	Method
1. Assessment of intraoperative haemodynamic stability.	2. Post-operative recovery status.

Trial Locations

Locations (1)

JSS MEDIACL COLLEGE ANAD HOSPITAL; 🇮🇳 Mysore, KARNATAKA, India

JSS MEDIACL COLLEGE ANAD HOSPITAL

🇮🇳Mysore, KARNATAKA, India

Dr KATTA VENKATA NAVEEN

Principal investigator

9160992667

naveen.katta77@gmail.com