Study the effect of Dexmedetomidine Drug in preventing Confusional State and agitation that occurs in patients undergoing urological surgery under general anaesthesia.
- Conditions
- Other intraoperative and postprocedural complications and disorders of genitourinary system,
- Registration Number
- CTRI/2021/09/036789
- Lead Sponsor
- Institutional Review Board IRB
- Brief Summary
The brain is vulnerable during the perioperative period among patients of all ages. Neu- robehavioral disturbances are among the commonly seen postoperative complications, of which three distinct forms are identiYied: emergence delirium, postoperative cognitive decline and the most severe form—postoperative delirium (POD).
POD manifests in patients who have undergone surgical procedures and anaesthesia, usually peaking between 1 and 3 days post surgery.
In the Indian population, POD is not uncommon following major abdominal surgery with its incidence ranging between 5 and 51%. In the urological population, it varies between 7.8- 30%.
In addition to causing physical harm to the patient, POD also causes major inconveniences in providing care to the postoperative surgical patient and seriously impacts both short and long term postoperative outcomes. It is often associated with an increase in hospital stay ,need for admission to a higher level of care , cognitive decline and even increased mortality and wors- ening quality of care.
The risk factors for developing POD are older age, cognitive impairment, severity of illness, psychopathological symptoms, preoperative depression, psychotropic drug use, greater co- morbidity, and perioperative complications. Patients undergoing urological procedures are of- ten old with multiple comorbidities and subclinical sepsis predisposing them to the develop- ment of POD .
Dexmedetomidine serves as a potent sedative with positive sedation and analgesic effects , anxiolytic ability, minimal respiratory depression, haemodynamic stability and prevention of neurotoxicity .The mechanism of dexmedetomidine is related to its highly selective stimula- tion of the alpha-2 adrenoreceptors.
Recent studies have shown that the use of dexmedetomidine is associated with the reduction of POD in patients in ICU and in the postoperative period especially in the cardiac population and the elderly.
We hypothesize that the use of dexmedetomidine in the intraoperative period along with the standard anaesthetic protocol of Balanced Anaesthesia will decrease the incidence of POD and provide stable intraoperative haemodynamics , better recovery profile and pain relief in the postoperative surgical population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 112
ASA 1,2 and 3 , Ages 17 to 65 Undergoing Urological Procedures under general anesthesia with endotracheal intubation.
- ASA 4 and above , Heart block , Preoperative bradycardia of Heartrate < 50.
- Psychiatric Illness and use of antipsychotics.
- Known allergy to dexmedetomidine.
- Pre operative Delerium assessed by a positive CAM.
- Patient refusal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative Delirium as assessed by CAM - ICU / CAM Score 7 Time points.T1-At recovery,T2-After 2 hours of recovery,T3-12 hours,T4-24 hours,T5-36hours,T6-48hours,T7-72 Hours
- Secondary Outcome Measures
Name Time Method Introperative Haemodynamics Recovery Profile
Trial Locations
- Locations (1)
Christian Medical College , Vellore Tamil Nadu - 632004
🇮🇳Vellore, TAMIL NADU, India
Christian Medical College , Vellore Tamil Nadu - 632004🇮🇳Vellore, TAMIL NADU, IndiaDr Tony MathewPrincipal investigator7508488133tonyjosef.93@gmail.com