Ketamine vs Midazolam on Cognitive Function in Elderly in Elective Surgery Three-Months Postoperatively (ketaminvsMDZ)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 160
Summary
- Conditions
- Cognitive Dysfunction
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Simple finite randomization will be performed. The anesthesiologist will choose an envelope with an assigned folio divided into two groups 1) intravenous infusion midazolam and 2) intravenous infusion ketamine, For sedation, regional anesthesia will be applied and hemodynamic variables, administered drugs, type of surgery, surgery time and transoperative bleeding will be recorded, after that, the cognitive evolution will be evaluated with the minimental examination at 3 months postoperativelyMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: the participant, the researcher and the outcomes assesor don't know the drug used for sedation.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 60 years and 85 years
- Gender
- Both males and females
Description
Randomized double blind clinical trial. Male and female patients 60-90 years of age scheduled in elective surgery under regional anesthesia and sedation. The researchers will be double blind and the data analyzer will ignore the drug used ( it it should be midazolam or ketamine in an intravenous inf...
Randomized double blind clinical trial. Male and female patients 60-90 years of age scheduled in elective surgery under regional anesthesia and sedation. The researchers will be double blind and the data analyzer will ignore the drug used ( it it should be midazolam or ketamine in an intravenous infusion). The principal investigator will limit himself to collecting the questionnaires and following up to 3 months. Simple finite randomization in two groups, will be done through envelopes. The pre-surgical, post-surgical Mini Mental questionnaire will be applied on the first day, 1 month and 3 months. During the trans-anesthetic, hemodynamic variables and anesthetic depth index measurements will be taken, surgical time, estimated bleeding, use of other adjuvant medications, type of surgery and comorbidities will be taken as intervening variables.
Tracking Information
- NCT #
- NCT04134052
- Collaborators
- Instituto Mexicano del Seguro Social
- Investigators
- Study Director: Oscar-Alberto Newton-Sanchez, Phd Universidad de Colima Principal Investigator: Fabian Rojas-Larios, Phd Universidad de Colima
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