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NCT Number: NCT06768580

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

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.

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Key information

Conditions

Oral Melatonin Confusion Delirium Elderly Patients Emergence Delirium Lidocaine Infusion Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Delirium Signs and Symptoms Total Hip Arthroplasty

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Alshaimaa S Alasrag, Master

CONTACT

[email protected]

00201018940354

Hoda A Ezz, MD

SUB_INVESTIGATOR

Kamal E Heikal, MD

SUB_INVESTIGATOR

Naglaa K Khalil, MD

SUB_INVESTIGATOR

Shaimaa E Shaban, MD

SUB_INVESTIGATOR

About this study

Delirium is defined according to The American Psychiatric Association's fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), as disturbance in attention and awareness developed over a short period of time , its severity tends to fluctuate during the course of a day, these disturbances cannot be better explained by other pre-existing neurocognitive disorders and do not occur in severely reduced arousal level such as coma. Delirium can be further classified into hyperactive, hypoactive and mixed.Postoperative delirium (POD) usually occurs in the recovery room and appears up to 5 days after surgery.

The prevalence of POD in elderly patients undergoing surgery varies from 20% to 45%. Patients undergoing hip fracture surgery are at higher risk of POD than patients undergoing other types of surgery. This may be related to their older age, higher incidence of comorbidities, and greater physical weakness.

Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone that is discharged by the pineal gland produced from the amino acid tryptophan. Synthetic melatonin has been effectively utilized in the treatment of sleep disorders. It was likewise utilized as a premedication and it provided excellent anxiolysis, sedation, and sympatholytic impacts with the merit of not influencing the patients' cognition in addition to its analgesic effect.

Lidocaine, an amide local anesthetic and class-1 antiarrhythmic with sedative and anti-inflammatory properties, is increasingly used as a part of a multimodal intraoperative anesthetic adjunct in a variety of surgical procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Allergy to lidocaine or melatonin.
  • Metabolic disorders and fluid, electrolytes disturbances.
  • Alcohol dependence or drug abuse.
  • Redo surgery or infectious complications.
  • CNS medications (antipsychotics, anticonvulsants, antiparkinsonian, antidepressants).
  • History of deep vein thrombosis.

Treatment and study plan

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.

Primary outcomes

  1. The incidence of postoperative delirium (POD)

    Time frame: 1st five days postoperatively

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

Secondary outcomes

  1. Severity of delirium

    Time frame: 1st five days postoperatively

    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).

  2. Onset of delirium

    Time frame: 1st five days postoperatively

    The onset of delirium will be recorded.

  3. Duration of delirium

    Time frame: 1st five days postoperatively

    The duration of delirium will be recorded.

  4. Degree of pain

    Time frame: 24 hours postoperatively

    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.

  5. Length of hospital stay

    Time frame: Till the discharge from the hospital (up to 2 weeks).

    Length of hospital stay will be recorded from the admission till the discharge from the hospital.

  6. Adverse effects

    Time frame: 24 hours Postoperatively

    Any undesirable side effects that may occur intraoperatively or postoperatively will be recorded and treated (e.g., nausea, vomiting, bradycardia, hypotension, respiratory depression and local anesthetic toxicity).

Study contacts

Contact information is provided by the study sponsor or research team.

Alshaimaa S Alasrag, Master

CONTACT

[email protected]

00201018940354

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty: Prospective Randomized Controlled Blinded Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2025
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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