Effects of Intravenous Dexmeditomidine Bolus Versus IV Dexmeditomidine Bolus with IV Lignocaine Infusion on Perioperative Hemodynamics in Patients Undergoing Short Laparoscopic Surgeries – A Randomized Controlled Trial.

This prospective study will be conducted on patients, aged between 20-40 years, belonging to

American Society of Anesthesiologists (ASA) Physical status I

and II, undergoing elective short laparoscopic surgeries under General anesthesia. After

obtainingthe informed written consent,

All patients included in the study will undergo thorough pre an aesthetic evaluation and

standard investigations as per ISA preoperative investigations guidelines. Patients will

be kept fasting as per ISA fasting guidelines 2019. On the day of surgery, patientswill be

shifted to operation theatre and basic routine monitors (ECG, NIBP and pulse

oximeter) are connected and baseline hemodynamic parameters -heart rate (HR), systolic blood

pressure (SBP), diastolic blood pressure (DBP) and mean blood arterial pressure (MABP)

recorded.

Randomization of study sample is done by simple randomization generated by using

www.randomization.com .Allocation concealment done by serially numbered opaque

envelope method (SNOSE technique). Study drugs are prepared by an anesthesia

resident not involved in the study. Administration of study drug and study observations

are done by another anesthesia resident blinded to the preparation of study drugs.

In the operating room, I V cannula will be secured, RL infusion will be started.

Inj. Glycopyrrolate 0.01mg/kg, inj. Midazolam 0.03mg/kg IV will be given.

Patients will be divided into 2 groups:

Group DL: Inj. Dexmedetomidine 0.6 mcg/kg IV bolus diluted to 10ml given over 10 mins &

inj. IV lignocaine bolus 1.5 mg/kg diluted to 10ml over 10min given and Inj. Lignocaine

1.5mg/kg/hr. infusion started before intubation with syringe pump.

Group D (Control Group): Inj. Dexmedetomidine 0.6 mcg/kg IV bolus diluted to 10ml given

over 10 mins & normal saline 10ml bolus over 10mins given and normal saline infusion

equivalent to study drug started before intubation with syringe pump.

Preoxygenation for 3min followed by IV Induction will be done with inj. Propofol

2mg/kg and in Vecuronium bromide 0.1mg/kg.

Endotracheal intubation will be done by appropriate endotracheal tube and correct

position is confirmed by 5-point chest auscultation and capnography.

Anesthesia is maintained with air (66%), oxygen (34%), isoflurane 0.6 and intermittent

bolus doses of vecuronium bromide 0.02 mg/kg to provide surgical relaxation. Patients

are connected to circuit system and minute ventilation is adjusted to maintain ETCO2 of

35-45mmhg.

Following the completion of surgery and deflation of pneumoperitoneum the infusion of

study drugs is stopped. At the time of skin closure, isoflurane will be discontinued.

Residual neuromuscular blockade will be reversed with inj. neostigmine (0.05mg/kg)

and inj. glycopyrrolate (0.01mg/kg) IV. When the signs of adequate reversal are met,extubation is performed and shifted to post anesthesia care unit [PACU] after

confirming stable vital parameters. Quality of recovery is assessed by QoR40 scale over next

24hrs.

Parameters observed:

Hemodynamic parameters- systolic blood pressure (SBP), diastolic blood pressure

(DBP), mean arterial pressure (MAP) and heart rate (HR) and are recorded

At following intervals– on arrival into OT [basal value], after study drug bolus, pre

induction, post intubation at 1min, at every 5min and 15 mins till the initiation of

pneumoperitoneum insufflation, immediate post insufflation and every 15min till the end of

surgery.

Intraabdominal pressures will be maintained at 12-15 mm Hg.

Patients will be observed for bradycardia (HR below 20% of baseline), hypotension

(MAP below 20% of baseline) during intra-operative period.

Brady cardia is treated with in Atropine 0.6mg and hypotension with inj. mephentermine

6mg IV. MAP and HR above 20% baseline will be treated with IV labetalol 10-20mg.

In PACU-

1.Severity of surgical site pain is assessed by Numerical rating scale [NRS 0 -10] and duration

is noted for rescue analgesia if NRS ≥ 4at rest.

2.The incidence and severity of PONV will be assessed in PACU in both the groups by

applying [0-4] point verbal descriptive scale [VDS][10]:

0- no complaint

1-mild degree of nausea

2-moderate degree of nausea

3- Frequent vomiting

4- severe vomiting (continuous vomiting)

If VDS >2 – INJ ONDANSETRON 4mgIV given. The incidence and severity will be

noted.

3. The patients are discharged from PACU after attaining modified Aldrete score [12]

of 9/10.

All the above parameters are assessed at 5min, 15min, and 30min

followed by every hour till discharge from PACU.

Quality of recovery is assessed by QoR40 scale over next 24hrs.

Data management and statistics

The data will be entered in MS excel sheet and the averages / means, proportions / percentages , gradings are noted.

The continuous variables related to intraoperative Mean arterial pressure, SBP, DBP , Heart rate, SpO2, ECG noted at After study drug bolus,Pre induction, Post Intubation,1min, 5min,15mins, Pneumoinsufflation, Immediate-Post insufflation ,5min,15min,

30min and expressed in their respective units.

Postoperative monitoring in PACU pain NRS score, PONV in VDS score, aldrete score are expressed.And the other data related to patient’s characteristics such as age, address , diagnosis, basal vitals & the vitals trend intraoperatively and other data related to patient will be entered as necessary. The data will be checked for uniformity of distribution.