INTRODUCTION:

Laparoscopic surgery has replaced many open surgeries for various surgical conditions as it decreases morbidity and mortality with reduced hospital stay. The creation of an artificial pneumoperitoneum by insufflation of carbon dioxide is associated with tachycardia, hypertension, arrhythmias etc, while laryngoscopy and orotracheal intubation are another potent noxious stimuli provoking hemodynamic disturbance which can be detrimental to high-risk patients. Therefore, induction of anaesthesia is very crucial point especially in high-risk patients.

 Propofol produces general anaesthesia by facilitation of inhibitory neurotransmission mediated by GABA. It serves to reliably induce sedation, amnesia, has antiemetic and anticonvulsant effects.  But it has high incidence of pain on injection and produces dosedependent hypotension and respiratory depression.

 Ketamine is a dissociative anaesthetic agent with analgesic and cardiac stimulatory properties that increases heart rate, blood pressure, cardiac output and intracranial pressure. Therefore, its use as a single induction agent is limited.^[2]

But combining ketamine and propofol (Ketofol) may potentially reduce doses used from each drug and balance each other’s hemodynamic adverse effects thus providing a stable hemodynamic profile at induction with added advantage of decrease in incidence of postoperative nausea and vomiting (PONV).^[3] 

Hence, in this study, the aim is to compare the haemodynamic profile of patients undergoing laparoscopic surgeries under general anaesthesia following induction with propofol alone or propofol with ketamine^.

STUDY HYPOTHESIS:   

This study is based on the hypothesis that the admixture of propofol-ketamine can provide better hemodynamic stability than propofol alone during laparoscopic surgery under general anaesthesia.

 AIMS AND OBJECTIVES:

In this study, the aim is to compare of hemodynamic changes between propofol and ketofol as induction agents in patient undergoing laproscopic surgery under general anaesthesia.

OBJECTIVES:

Primary Outcome:

1. To compare Hemodynamic parameters (Heart rate, Systolic blood pressure, Diastolic blood pressure, Mean arterial pressure)

Secondary Outcome:

1. To compare incidence of pain on injection of induction agent.

2. To compare the incidence of postoperative nausea and vomiting.

STUDY DESIGN:  

Study Type: This study is a prospective, randomized, control study.

 Study Site: It is proposed to be conducted in the general surgery and gynaecology operation theatre at civil hospital, Ahmedabad.  

Study duration:  February 2025 to May 2025

Sample size calculation: The sample size was calculated using Med Cal Software from the reference study. Mean arterial pressure found to be 79.92 (±9.34) mmHg and 72.58 (±10.03) mmHg in group P and group KP respectively at T2 (following 1 minute of induction).

The difference of mean is 7.34, taking alpha error of 0.05 and power of study 80%, the sample size came to 28 in each group. So, considering 10% drop out rate, we will take 31 patients in each group.

 PATIENT SELECTION:

Inclusion Criteria:

Elective laproscopic surgery under general anaesthesia

 ASA Grades I, II, III

 Age 18 – 60 years

Either gender

 Exclusion Criteria:

 Patient giving negative consent

 Difficult airway

ASA Grade IV, V

Cardiopulmonary diseases, hypotension and shock

 Head injury and neurosurgery

Allergic to propofol(egg) and ketamine

MATERIALS AND METHODOLOGY:

After the Institutional Ethics Committee approval, CTRI registration and duly signed informed written consent this study will be started.

A thorough history will be taken, general and systemic examination will be carried out in all patients. Routine investigations include hemogram, RFT, LFT, electrolytes, ECG, Chest x-ray will be advised. Patients will be kept nil per oral for 6 hours before surgery.

BURDEN OF COST-

The study involves the use of drugs namely Injection Propofol and Injection Ketamine. Both drugs are supplied by Government Of Gujarat to Civil Hospital, Ahmedabad. If the drugs are not available, then expenses will be borne by me.

PREPARATION ON TABLE:

· In the operative room, multipara monitor will be attached and baseline parameters Heart rate, NIBP, SpO₂, EtCO₂ will be recorded.

· Intravenous line will be secured and will start Injection crystalloid (ringer lactate / dextrose saline) fluids.

· Premedication

o Injection Glycopyrrolate 0.004 mg/kg intravenously.

o Injection Ondansetron 0.16 mg/kg intravenously.

o Injection Fentanyl 2 µg/kg intravenously.

ANESTHESIA PROCEDURE:

· Randomization will be done using computer generated random number. Its allocation will be concealed using opaque envelope.

· All patients will be divided randomly into two groups.

o GROUP P: Patient will be given Injection Propofol 2.5 mg/kg diluted to 20 ml normal saline in a syringe till the loss of eyelash reflexes.

o GROUP KF: Patient will be given Injection Propofol 1 mg/kg plus Injection Ketamine 1 mg/kg diluted to 20 ml normal saline in a syringe till the loss of eyelash reflexes.

· Induction will be done after pre-oxygenation with 100% oxygen for 3-5 minutes.

· Intubation will be facilitated by Injection Succinyl Choline 2 mg/kg intravenously. Trachea will be intubated with appropriate sized cuffed, portex, disposable endo-tracheal tube. (ET tube 7-7.5mm ID for female and 8-8.5mm ID for male) After checking bilateral air entry ET tube will be fixed.

·  Maintenance of anesthesia: O₂+N₂O (50:50) mixture with Sevoflurane 1.5-2% and      Injection Atracurium Besylate 0.5 mg/kg loading dose, followed by 0.1 mg/kg maintenance dose intravenously.

· Reversal: At the end of surgery, neuro-muscular blockade will be reversed with Injection Neostigmine 0.05 mg/kg and Injection Glycopyrrolate 0.008 mg/kg intravenously.

· Extubation: After thorough oropharyngeal suction, patient will be extubated once protective airway reflexes are established with adequate tidal volume, hemodynamic stability, consciousness and adequate motor tone and power.

All patients will be observed for,

Patient’s hemodynamic parameters i.e. NIBP, HR, SpO₂, EtCO₂ will be recorded from preoperatively at the time of premedication, induction, one minute following laryngoscopy and Intubation then every 5 minutes till 10 minutes and then every 15 minutes till surgery lasts.

 DATA ANALYSIS:

The collected data will be analysed using statistical package for social sciences. Hemodynamic parameters studied during observation period will be compared with unpaired T test. The various categorical data analysis using chi square test. P<0.05 will be considered statistically significant. 

STUDY END POINT:

 Till 6 hours of postoperative period to observe PONV.