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Clinical Trials/CTRI/2025/04/084031
CTRI/2025/04/084031
Not yet recruiting
Phase 3 4

TO COMPARE THE EFFICACY OF TWO DIFFERENT DOSES OF DEXMEDETOMIDINE ON HEMODYNAMIC RESPONSE DURING DL AND EI IN PATIENT UNDERGOING LAPROSCOPIC SURGERY UNDER GA. A RANDOMIZED CONTROLLED STUDY

ESIPGIMSR MEDICAL COLLEGE AND HOSPITAL1 site in 1 country98 target enrollmentStarted: April 17, 2025Last updated:

Overview

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
ESIPGIMSR MEDICAL COLLEGE AND HOSPITAL
Enrollment
98
Locations
1
Primary Endpoint
IV Dexmedetomidine 1 mcg/kg is more effective than intravenous Dexmedetomidine 0.75mcg in suppressing pressor response during laryngoscopy and intubation in patients undergoing laparoscopic surgery.

Overview

Brief Summary

Secure airway for proper ventilation during anaesthesia is one of the most important component of a successful surgery . Many drugs are used to reduce the hemodynamic stress response during laryngoscopy and endotracheal intubation. The question for ideal drugs and their dosage without major side effects is still pursued . This research aimed to investigate the impact of two different doses of Dexmedetomidine in mitigating the stress response during laryngoscopy and endotracheal intubation. Dexmedetomidine is an alpha-2 receptor agonist and shorter acting than clonidine, is emerging as a promising drug to counteract the catecholamine release.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients between 18 to 60 years of age ASA physical status 1 and 2 with airway Mallampati Grade 1 and 2.

Exclusion Criteria

  • Refusal pregnant patient on beta blockers morbid patients Full stomach on alpha 2 agonist patient suffering from heartblock or sicksinus syndrome.

Outcomes

Primary Outcomes

IV Dexmedetomidine 1 mcg/kg is more effective than intravenous Dexmedetomidine 0.75mcg in suppressing pressor response during laryngoscopy and intubation in patients undergoing laparoscopic surgery.

Time Frame: Preparatory phase- 2 month | Phase of data collection- 08 months | Phase of data analysis- 02 months | d. Report writing & submission- 02 months

Secondary Outcomes

  • To compare the efficacy of two different doses of Dexmedetomidine on hemodynamic response during direct laryngoscopy & endotracheal intubation in patient undergoing laparoscopic surgery under general anaesthesia(Hemodynamic parameters like the Heart rate systolic & diastolic blood pressure & mean arterial pressure will be measured 15 minutes after drug administration & 1 min 3mins 5mins 10mins 15mins post intubation)

Investigators

Sponsor
ESIPGIMSR MEDICAL COLLEGE AND HOSPITAL
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Hariharan V

ESIC Medical college and hospital

Study Sites (1)

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