The study the effect of intranasal and intravenous dexmeditomidine

Phase 3

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/09/057760
• Lead Sponsor: Vardhman Mahavir Medical College New Delhi

Brief Summary

METHODOLOGY

All patients satisfying inclusion criteria will undergo detailed preanaesthetic evaluation. After explaining the nature of the study, an informed consent will be obtained from all patients willing to participate in the study, followed by a complete physical examination.

100 adults, will be included in this study. All patients will be randomly allocated to one of study groups using computer generated randomization. The patients will be then divided into two groups Group -A(Intravenous dexmeditoidine) and Group B(Intranasal dexmeditomidine). All patients of both groups will be advised for fasting of 6 hours and premedication of tablet ranitidine (150 mg) and alprazolam (0.5 mg) on the night before surgery.



On the day of operation, all patients will be shifted to preoperative room 2 h before the operation time. Monitoring like electrocardiography (ECG), plethysmography (SPO2), non- invasive blood pressure (NIB) monitoring will be attached and baseline readings will be obtained. Intravenous access(18G) will be secured and IV Ringer’s lactate solution will be administered as maintenance fluid. The study drug will be prepared and given by some senior anaesthesiologist and monitoring of parameters will be done by different anaesthesiologist.

Group A(Dexmeditomidine intravenous) will be given IV DEXMEDITOMIDINE (0.50 ug/kg) diluted in 40 ml of normal saline (NS) through an infusion pump over 40 min and I ml of NS intranasal will be instilled in equal volume in both nostrils before induction at the same time.

Group B(Dexmeditomidine intranasal) will be instilled Im| DEXMEDITOMIDINE in both nostrils in equal volume and 40ml of normal saline (NS) intravenously through an infusion pump over 40 min before induction. All the patients of both groups will be advised not to sneeze or suck after intranasal drug administration.



Then after completion of study drug administration, patient will be shifted in the operation room, standardised monitoring like electrocardiography (ECG), plethysmography (SP02). noninvasive blood pressure (NIBP), End tidal carbondioxide (EtCO2) monitoring will be connected and before induction readings will be noted.



All patients will be pre- oxygenated with 100% oxygen for 3 minutes. Fentanyl citrate 2 meg/kg, and titrated dose of Propofol 1-2 mg/kg will be given over 45second till the loss of consciousness . After ensuring check ventilation , vecuronium bromide 0.1 mg/kg body weight will be administered intravenously. Patient will be ventilated with mixture of oxygen + NO(50:50) and Isoflurane (MAC- 1) for 4 min and then endotracheal intubation with appropriate cuffed endotracheal tube will be performed. After confirming for bilateral equal airentry, the endo-tracheal tube will be fixed and normocapnic ventilation will be started with monitoring of ECG, HR, NIBP/IBP, EtCO2 and SpOz Readings at 2,5,7and 9 minutes after intubation will be noted Maintenance of anaesthesia will be continued with 02 + NO(40:60) and Isoflurane (MAC-1) All haemodynamic parameters will be monitored continuously and any adverse events like bradycardia, tachycardia, hypertension, hypotension or arrhythmia will be recorded and appropriate management will be done. Additional doses of neuromuscular blockade i.e. inj. vecuronium bromide 0.025mg/kg as and when required and analgesic inj. fentanyl 1meg/kg one and hourly would be given according to duration of surgery. Inj Ondansetron 4mg intravenous will be given 30 min before end of surgery.

After completion of surgery, neuromuscular block will be reversed by appropriate dose of IV neostigmine (0.05 mg/kg) and glycopyrolate (0.01 mg/kg).



After adequate muscle power recovery patient will be extubated and will be shifted to the recovery room after stabilization Patents vitals will be monitored there for 2 h and when Modified Alderate score ›9, the patient will be shifted to ward.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-16
• Study Start: 2023-09-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Adult patients belonging to ASA grade I &II 2.Scheduled for elecytive surgery under general anaestheia.

Exclusion Criteria

• Uncooperating, non consenting patients.
• Known allery or hypersenstivity to dexmeditomidine.
• Pregnant, lactating mothers, Cardiac or respratory disease, uncontrolled hypertension, diabetes mellitus type II, neurological or psychiatric disease, or any intranasal pathology{like nasal ulcers, polyps, nasaal septal deviation}.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean arterial pressure{MAP}	40 minutes before induction, 2 min before induction, 2,5,7,9 min after induction.

Secondary Outcome Measures

Name	Time	Method
Systolic blood pressure{SBP}, diastolic blood pressure{DBP} & heart rate.	40 minutes before induction, 2 min before induction, 2,5,7,9 min after induction.

Trial Locations

Locations (1)

Vardhman Mahavir Medical College and Safdarjung Hospital; 🇮🇳 West, DELHI, India

Vardhman Mahavir Medical College and Safdarjung Hospital

🇮🇳West, DELHI, India

Dr Himanshu Gautam

Principal investigator

9717312007

himanshugautam9441@gmail.com