Delirium in Old Age
Conditions
Brief summary
The present study will evaluate the role of melatonin prophylaxis in delirium prevention in elderly patients undergoing colorectal procedures.
Detailed description
This study is a prospective randomised double-blind placebo-controlled trial. Patients who meet the criteria for inclusion/exclusion will be evaluated. Melatonin tablets will be administered as a premedication to patients in the melatonin group. Patients in the control group will be given placebo tablets as a premedication. Fentanyl 1ug/kg and propofol 1-2 mg/kg will be used to induce anaesthesia. Atracurium 0.5 mg/kg will be used for the facilitation of endotracheal intubation. Isoflurane will be used to maintain anaesthesia and the depth of anaesthesia will be adjusted by a Bispectral index monitor. Postoperatively, the patients will be monitored for the development of delirium.
Interventions
DRUGMelatonin
The patients will be given 5 mg melatonin the night before surgery, 12 hours before the scheduled time of surgery, followed by another 5 mg melatonin two hours before surgery.
DRUGPlacebo
The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group.
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Society of Anaesthesiologists (ASA) I to III physical status * Elective colorectal procedures
Exclusion criteria
* Allergy to the research drugs, * Patients who have vision or hearing impairment * History of cerebral disorders * Uncorrected acid-base, fluid, and electrolyte abnormalities * History of central nervous system function affecting drugs. * Chronic sedative-hypnotic administration at least one month prior to surgery * Alcohol abuse * Patients with recorded preoperative nursing delirium screening score ≥ 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of delirium occurrence | Perioperative. | Nursing delirium - screening score. It scores five items,Each item is rated from 0 to 2 where 0, absent; 1, mild; 2, severe. A score ≥ 2 is considered to have delirium. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of pain | Perioperative | Pain Assessment in Advanced Dementia Scale from 0 to 10 . score 1 to 3=mild pain; 4 to 6=moderate pain; 7-to 10=severe pain. |
| Mean arterial blood pressure | Perioperative | mmHg |
| Heart rate | Perioperative | beats/minute |
| Degree of Sedation | Perioperative. | Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation |
| Hypoxia | Perioperative | Number of patients with hypoxia |
| Blood transfusion needs | Perioperative | Number of patients needed blood transfusion |
| Hypotension | Perioperative | Number of patients with hypotension |
Countries
Egypt
Outcome results
None listed