Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorTanta University

About this trial

The aim of this study is to assess the effect of oral melatonin versus intraoperative lidocaine infusion on incidence of postoperative delirium in elderly patients undergoing total hip arthroplasty under spinal anesthesia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Elderly patients aged >65 years old undergoing unilateral total hip arthroplasty.

Patients with body mass index (BMI) (18-30) kg/m2.

American Society of Anesthesiologists (ASA) physical status I-III, scheduled to undergo unilateral total hip arthroplasty.

Disqualifiers

History of mental illness or scoring less than 8 using abbreviated mental test (AMT) before operation.

Obvious sinus bradycardia (heart rate of <50 beats per minute) or other serious cardiovascular diseases.

Symptomatic cerebrovascular disease (such as previous stroke).

History of liver and kidney dysfunction.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Melatonin

    Drug

    Patients will receive one capsule of melatonin (5mg) orally the night before surgery at 9 pm, the night of the operation, and two nights after the surgical operation at 9 pm, also the patients will receive 10 ml bolus of saline intravenous (IV) over 10 min before induction of anesthesia, then continuous infusion of saline (20 ml/hr) until the end of surgery.

  • Lidocaine

    Drug

    Patients will receive a bolus (10 ml) of intravenous lidocaine (1mg/kg) diluted with saline over 10 min before induction of anesthesia. Continuous infusion of 1.5 mg/kg/hr of intravenous lidocaine diluted with saline (20 ml/hr) will be administered until the end of the surgery, also will receive placebo capsule the night before surgery at 9 pm, the night of operation and two nights after the surgical operation at 9 pm.

  • Placebo

    Drug

    Patients will receive a bolus (10 ml) of saline over 10 min before induction of anesthesia, then continuous infusion of saline (20 ml/hr) and placebo capsule the night before surgery at 9 pm, the night of the operation and two nights after the surgical operation at 9 pm.

Treatment groups

135 Participants
are divided into 3 treatment groups
Group A: Melatonin groupExperimental treatment 1 intervention
Group B: Lidocaine groupExperimental treatment 1 intervention
Group C: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of postoperative delirium (POD)

Incidence of postoperative delirium in elderly patients undergoing total hip arthroplasty will be recorded

Time frame
1st five days postoperatively

Secondary outcomes

1

Severity of delirium

Severity of delirium will be assessed using (CAM-S) score. The sum of the CAM-S scores ranges from 0 to 7 (7 = most severe).

Time frame
1st five days postoperatively
2

Onset of delirium

The onset of delirium will be recorded.

Time frame
1st five days postoperatively
3

Duration of delirium

The duration of delirium will be recorded.

Time frame
1st five days postoperatively
4

Degree of pain

Postoperative pain will be assessed using the visual analogue scale (VAS) score (0 point indicates no pain and 10 indicate maximum pain). Patients will receive epidural analgesia if VAS score is ≥4.

Time frame
24 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.