Clinical trial

The Effect of Ketamine - Dexmedetomidine Admixture (Ketodex) on Hemodynamic Stability During Anesthesia Induction in Adults: A Randomized Controlled Comparison of Two Doses

Name
MS-94-2023
Description
The aim of our study to compare two different doses of Dexmedetomidine added to anesthetic dose of ketamine in the induction of general anesthesia in adult patients regarding the hemodynamic profile, adequacy of hypnosis, intubation conditions and recovery type. We hypothesize that the use of Ketodex during induction of general anesthesia will produce better control regarding the hemodynamic profiles and quality of intubation than propofol.
Trial arms
Trial start
2023-10-25
Estimated PCD
2024-10-01
Trial end
2024-11-01
Status
Recruiting
Phase
Early phase I
Treatment
ketamine- dexmeditomidine admixure
ketamine in anesthetic dose mixed with two different doses of dexmeditomidine
Arms:
Ketamine-Dexmedetomidine (KD3) group, Ketamine-Dexmedetomidine (KD5) group
Propofol, Lidocaine and fentanyl
Propofol (2mg/kg) prepared as will be mixed with 2 mL Lidocaine (40 mg) for concentration 10mg/ml and fentanyl (1mic/kg) prepared for concentration 10mg/ml
Arms:
Propofol (P) group
Size
114
Primary endpoint
Incidence of post-induction hypotension
the first 20 min after general anaesthesia induction.
Eligibility criteria
Inclusion Criteria: - All patients undergoing elective general surgery. Patients aged \>18 years. ASA I and II. Both sexes. Exclusion Criteria: * All patients undergoing emergency surgery. Patients less than 18 years. History of difficult intubation, abnormal airway examination Cardiac morbidities (impaired contractility with ejection fraction \< 50%, heart block, arrhythmias, tight valvular lesions). Patients on angiotensin converting enzyme inhibitors and angiotensin receptor blockers medications. Patients with uncontrolled hypertension. Patients with allergy of any of the study drugs. Body mass index \> 35 kg/m2
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients will be divided into 3 equal groups: Propofol group (p), Ketamine-Dexmedetomidine (KD5) group and Ketamine-Dexmedetomidine (KD3) group.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 114, 'type': 'ESTIMATED'}}
Updated at
2024-05-14

1 organization

2 products

1 indication

Product
Propofol