Oral MelatoninNCT06768580
Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty
A study testing Melatonin and Lidocaine in people with Oral Melatonin and Lidocaine Infusion, run by Tanta University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Oral Melatonin, Lidocaine Infusion, Postoperative Delirium
- What is being tested?
- Melatonin and Lidocaine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Alcohol dependence or drug abuse.
- Redo surgery or infectious complications.
- CNS medications (antipsychotics, anticonvulsants, antiparkinsonian, antidepressants).
- History of deep vein thrombosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Alshaimaa S Alasrag, Master, 00201018940354, alshaimaa.alasrag@med.tanta.edu.eg
Kamal E Heikal, MD
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Oral Melatonin, Lidocaine Infusion, Postoperative Delirium, Elderly Patients, Total Hip Arthroplasty
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
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.
LidocaineDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin group | Experimental | 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. Receives: Drug: Melatonin |
| Lidocaine group | Experimental | 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. Receives: Drug: Lidocaine |
| Control group | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of postoperative delirium (POD)
Incidence of postoperative delirium in elderly patients undergoing total hip arthroplasty will be recorded
Measured: 1st five days postoperatively
Secondary outcomes (6)
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).
Measured: 1st five days postoperatively
Onset of delirium
The onset of delirium will be recorded.
Measured: 1st five days postoperatively
Duration of delirium
The duration of delirium will be recorded.
Measured: 1st five days postoperatively
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.
Measured: 24 hours postoperatively
Length of hospital stay
Length of hospital stay will be recorded from the admission till the discharge from the hospital.
Measured: Till the discharge from the hospital (up to 2 weeks).
Adverse effects
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).
Measured: 24 hours Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start15 Jan 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MelatoninStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshaimaa Soliman Alasrag, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768580
- Sponsor's protocol ID
- 36265MD277/9/24
- Status last verified
- Apr 2025
- First submitted
- 6 Jan 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06768580
- Acronym / sponsor ID
- 36265MD277/9/24
- Conditions
- Oral Melatonin, Lidocaine Infusion, Postoperative Delirium, Elderly Patients, Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Melatonin group | Experimental | Drug: MelatoninPatients 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 group | Experimental | Drug: LidocainePatients 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. |
| Control group | Placebo comparator | Drug: PlaceboPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninPatients 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. | Drug | Melatonin group |
| LidocainePatients 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. | Drug | Lidocaine group |
| PlaceboPatients 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. | Drug | Control group |
Primary outcome
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
6 secondary outcomes
Severity of delirium
Time frame: 1st five days postoperatively
Onset of delirium
Time frame: 1st five days postoperatively
Duration of delirium
Time frame: 1st five days postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Length of hospital stay
Time frame: Till the discharge from the hospital (up to 2 weeks).
Adverse effects
Time frame: 24 hours Postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin and Lidocaine in people with Oral Melatonin and Lidocaine Infusion, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alshaimaa S Alasrag, Master (00201018940354, alshaimaa.alasrag@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative delirium (POD) (time frame: 1st five days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.