Comparison of Intravenous Midazolam and Dexmedetomidine when given before operation in Laproscopic cholecystectomy with CNS monitoring with Propofol for induction of Anaesthesia.

Not yet recruiting

Conditions: Calculus of gallbladder with acutecholecystitis,

Registration Number: CTRI/2022/09/045193

Lead Sponsor: Sharda Hospital

Brief Summary: Surgery and anaesthesia is a stressful condition and areassociated with stimulation of neuroendocrinal pathway, producing varioushemodynamic effects, which may be harmful for the patient. Methods to decreasethese effects include maintaining an adequate depth of anaesthesia to preventthese hemodynamic effects, or to give some pharmacological preparation to thepatients, which will modify the response of anaesthetic drugs

Premedication is a part of pre-anaesthesia preparation whichaims to prepare patients both physically and mentally for anaestheticprocedures. The main goal of pre-treatment is to eliminate anxiety. There areseveral classes of drugs used for the purposes of premedication, includingsedatives, alpha-2 adrenergic agonists, anticholinergics, narcotics,antihistamines, antacids, and H2 antagonists

Included in the sedative group are barbiturates,benzodiazepines, and butyrophenones. Midazolam belongs to benzodiazepine group,which is water soluble. It is short acting, widely used as an anxiolytic,sedative, and anaesthetic adjuvant, and has numerous advantages, such as ashort elimination half-life, a significant anterograde amnesia, mildrespiratory depression, and a relief of anxiety

Dexmedetomidine is a highly selective alpha 2 adrenergicreceptor agonist and possesses the potential benefit of sedation,sympatholysis, analgesia, and cardiovascular stability, Its hemodynamic effectsare predictable and dose dependent. Dexmeditomidine, at clinically effectivedosages, does not depress respiration, and therefore does not interfere withextubation

Laparoscopic surgery is a modern surgical technique involvinginsufflation of gas (usually CO2) into the peritoneal cavity under pressure toseparate organs from abdominal cavity. Laparoscopic cholecystectomy hasrevolutionized gall bladder surgeries and it has now become the gold standard forthe treatment cholelithiasis

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 78

Inclusion Criteria

Patient scheduled for elective laproscopic cholecystectomy 2.
age 18-60 years 3.
both genders 4.
ASA grade 1 and 2.

Exclusion Criteria

1. Patients refusal to participate in study 2. Morbid obesity BMI >30 3. History of sleep apnoea 4. Pharmacological therapy.
Benzodiazipines, opoids , antipsychotics 5. anticipated difficult intubation 6. Sinus bradycardia or bundle branch block on ECG 7. Pregnant females 8. coagulopathy or bleeding diathesis 9. history of hypertension , diabetes mellitus, thyroid disease. 10. history of CNS , cardiovascular and renal diesease.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the induction dose of propofol , in the three groups , midazolam , dexmedetomidine and the control group	We will monitor Heart Rate, Blood Pressure, Oxygen saturation ,Bispectral Index Value at - \| Preoperative period \| Preinduction period \| Preintubation . \| At The Time of intubation. \| Post intubation every minute till 10 minutes then \| every 10 minute till the end of surgery \| then we will monitor the outcome with modified Aldrete score post operatively.

Secondary Outcome Measures

Name	Time	Method
1. To compare the haemodynamic changes between different groups during intubation.	2. To compare the recovery profile between different groups.

Trial Locations

Locations (1): Sharda Hospital , school of medical sciences and research
🇮🇳
Nagar, UTTAR PRADESH, India
Sharda Hospital , school of medical sciences and research
🇮🇳Nagar, UTTAR PRADESH, India
Dr habiba Atif
Principal investigator
8127472129
atif.habiba@gmail.com