Clinical trial

Attenuation Of Hemodynamic Response To Laryngoscopy. Role Of Dexmedetomidine. A Dose Finding Study

Name
SindhInstitute
Description
Two doses of Dexmedetomidine (0.5 µ/kg and 0.75 µ/kg) will be used to attenuate the stress response to laryngoscopy in American Society of Anesthesiology, physical class I patients which will be compared with the placebo-controlled group.
Trial arms
Trial start
2021-08-23
Estimated PCD
2021-12-13
Trial end
2021-12-13
Status
Completed
Phase
Early phase I
Treatment
Normal saline
Normal saline 20mL will be given intravenously through a syringe pump over 10 minutes
Arms:
Dexmedetomidine 0.5, Dexmedetomidine 0.75, Placebo
Other names:
Placebo group
Dexmedetomidine 0.5 microgram/kg
Dexmedetomidine 0.5 microgram/kg diluted in 20mL of normal saline will be given intravenously through a syringe pump over 10 minutes
Arms:
Dexmedetomidine 0.5
Dexmedetomidine 0.75 microgram/kg
Dexmedetomidine 0.75 microgram/kg diluted in 20mL of normal saline will be given intravenously through a syringe pump over 10 minutes
Arms:
Dexmedetomidine 0.75
Size
105
Primary endpoint
Hemodynamic Response
0 to 10 minutes after endotracheal intubation
Eligibility criteria
Inclusion Criteria: * Age between 18 to 55 years * ASA I or II patients undergoing surgery under general anaesthesia with endotracheal intubation. * Patients with Mallampati class I or II. Exclusion Criteria: * ASA III \& IV patients * Anticipated or unanticipated difficult intubations which requires more than 15 seconds or more than one attempt. * Patients with Mallampati class III, IV or with loose teeth. * Patients with inotropes infusion. * Patients with known allergy to any anaesthetic agents * Patients with a heart rate of 60 beats/min or less * Patients with known hypertension, incidental finding of hypertension while on operating table, diabetes, ischemic heart disease or peripheral vascular disease. * Pregnant and lactating mothers.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 105, 'type': 'ACTUAL'}}
Updated at
2023-06-18

1 organization

1 product

1 drug

3 indications

Indication
intubation
Indication
Dexmedetomidine