AnesthesiaNCT06355687
Melatonin in Obese Patients in Laparoscopic Cholecystectomy
A study testing Melatonin and Vitamin Supplement in people with Anesthesia, run by Ain Shams University.
Trial summary
Opioid free anesthesia (OFA) means a technique in which no intraoperative opioid is administered through any route. Perioperative pain management in an obese patient is challenging. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Melatonin and Vitamin Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-45 years.
- Body Mass Index: Over 30 kg/m2.
- Physical Status: ASA classification I and II.
Who cannot join
- Patient refusal.
- Age: Less than 18 years, more than 45 years.
- Patients with known history of allergy towards one of the study drugs.
- Patients with severe cardiac, respiratory, hepatic or renal disease.
- Body Mass Index: Under 30 kg/m2.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Evaluation of Adding Melatonin to Opioid Free Anesthesia on Postoperative Pain in Obese Patients Undergoing Laparoscopic Cholecystectomy
Opioid free anesthesia (OFA) means a technique in which no intraoperative opioid is administered through any route. Perioperative pain management in an obese patient is challenging. The incidence of respiratory depression is higher in obese patients and is exaggerated with opioids, so the investigators are searching for a drug that has analgesic effect without any effect on respiratory function. In this study, the investigators will add melatonin to OFA in obese patients undergoing laparoscopic cholecystectomy.
Read the detailed description
Obesity leads to a restrictive lung disease, causing reduction in functional residual capacity and total lung compliance.
When an obese patient is supine and anesthetised, the depressant effects of many anesthetic agents and analgesics, particularly opioids, further decrease the lung compliance, leading to increased hypoxemia.
Opioid based general anesthesia in these patients increases the incidence of postoperative respiratory depression, atelectasis, and pneumonia. Also, pain relief with opioids is associated with sedation, hence impeding rapid recovery and early mobilization.
OFA is the use of multimodal or balanced analgesia. The principle of this is to gain additive analgesic effects from different drugs while minimizing side effects, particularly those of opioids. Studies have shown that OFA fast tracks surgery, reduces hospital stay, promotes early mobilization, and enteral nutrition.
Prior studies which investigated opioid free techniques are based on the combination of drugs acting on sympathetic nervous system, perioperative administration of local anesthetics, nonsteroidal anti-inflammatory drugs, and of adjuvant drugs, such as ketamine, magnesium etc.
Laparoscopic surgery is more challenging in obese patients since they have excessive pneumoperitoneal insufflation pressures, longer anesthetic, surgical, and recovery times. Moreover, these procedures are usually done in Trendelenburg position which further leads to increased airway resistance.
Melatonin is mainly secreted from the pineal gland by the suprachiasmatic nucleus. This neurohormone possesses a circadian secretion pattern and regulates the biological clock; it also offers antiemetic, analgesic, and anxiolytic effects. Due to its effect on both acute and chronic pain, melatonin fulfills a beneficial role in reducing postoperative opioid consumption while minimizing nausea and vomiting. In addition, melatonin can be used to moderate the effect of light on the autonomic system.
Several studies have reported that melatonin, as an analgesic, anti-inflammatory, anxiolytic, and anti-agitation premedication, is associated with sedation and anxiolysis without adverse effects on recall and driving performance.
- Conditions
- Anesthesia
- Being tested
- Melatonin, Vitamin Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Also called Circadin
Obese patients undergoing laparoscopic cholecystectomy will receive melatonin oral (0.2 mg /kg) 45 minutes before general anesthesia.
Vitamin SupplementDietary supplement
Obese patients undergoing laparoscopic cholecystectomy will receive placebo medication (Vitamin Supplement) 45 minutes before general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| The Melatonin group | Active comparator | Melatonin group: A total of 30 obese patients undergoing laparoscopic cholecystectomy will receive melatonin oral (0.2 mg /kg) 45 minutes before general anesthesia. Receives: Drug: Melatonin |
| The Control group | Placebo comparator | Control group: A total of 30 obese patients undergoing laparoscopic cholecystectomy will receive placebo medication (Vitamin Supplement) 45 minutes before general anesthesia; Control group. Receives: Dietary Supplement: Vitamin Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain.
Numeric Rating Scale (NRS); is a pain screening tool, commonly used to assess pain severity at that moment in time using a (0-10) scale, with (0) meaning no pain and (10) meaning the worst pain imaginable.
Measured: Will be evaluated postoperatively at time of delivery to Post Anesthesia Care Unit (PACU) (Zero time) and every 5 minutes for 30 minutes.
Secondary outcomes (6)
Postoperative Pain.
Numeric Rating Scale (NRS); is a pain screening tool, commonly used to assess pain severity at that moment in time using a (0-10) scale, with (0) meaning no pain and (10) meaning the worst pain imaginable.
Measured: Will be evaluated at time of 30 minutes after delivery to PACU and hourly for 4 hours.
Analgesics usage.
The total dose of analgesics consumption was used postoperatively per patient rescue analgesia.
Measured: Will be evaluated postoperatively (Zero time) and every 15 minutes for 1 hour.
Postoperative nausea and vomiting.
The occurrence of postoperative complications including postoperative nausea and vomiting.
Measured: Will be evaluated postoperatively (Zero time) and every 15 minutes for 1 hour.
Recovery time.
The time between patient admission to PACU and being discharged from it.
Measured: Will be evaluated at time of admission to PACU and every 15 minutes for 1 hour until being discharged from it.
Number of participants with hemodynamic instability.
Intraoperative hemodynamic stability data (Systolic blood pressure; in mmHg, Diastolic blood pressure; in mmHg, and Mean arterial pressure; in mmHg)
Measured: Will be evaluated at the start of the operation and every 5 minutes throughout the operation until delivery to PACU and every 15 minutes for 1 hour until being discharged from it.
Number of participants with hemodynamic instability.
Intraoperative hemodynamic stability data (Heart rate; in beats per second)
Measured: Will be evaluated at the start of the operation and every 5 minutes throughout the operation until delivery to PACU and every 15 minutes for 1 hour until being discharged from it.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Farid Ibrahim Mahmoud, Ain Shams University
- Investigators
- Hala GO Salama, MD, Principal investigator, Faculty of Medicine, Ain Shams UniversityReham MU Hashim, MD, Principal investigator, Faculty of Medicine, Ain Shams UniversityWalid YO Youssef, MD, Principal investigator, Faculty of Medicine, Ain Shams UniversityDiaaeldein MA Haiba, MD, Principal investigator, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355687
- Sponsor's protocol ID
- FMASU MD304/2023
- Status last verified
- Apr 2024
- First submitted
- 10 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Adding Melatonin to Opioid Free Anesthesia on Postoperative Pain in Obese Patients Undergoing Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06355687
- Acronym / sponsor ID
- FMASU MD304/2023
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 9 Apr 2024 (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.
Opioid free anesthesia (OFA) means a technique in which no intraoperative opioid is administered through any route. Perioperative pain management in an obese patient is challenging. The incidence of respiratory depression is higher in obese patients and is exaggerated with opioids, so the investigators are searching for a drug that has analgesic effect without any effect on respiratory function. In this study, the investigators will add melatonin to OFA in obese patients undergoing laparoscopic cholecystectomy.
Detailed description
Obesity leads to a restrictive lung disease, causing reduction in functional residual capacity and total lung compliance.
When an obese patient is supine and anesthetised, the depressant effects of many anesthetic agents and analgesics, particularly opioids, further decrease the lung compliance, leading to increased hypoxemia.
Opioid based general anesthesia in these patients increases the incidence of postoperative respiratory depression, atelectasis, and pneumonia. Also, pain relief with opioids is associated with sedation, hence impeding rapid recovery and early mobilization.
OFA is the use of multimodal or balanced analgesia. The principle of this is to gain additive analgesic effects from different drugs while minimizing side effects, particularly those of opioids. Studies have shown that OFA fast tracks surgery, reduces hospital stay, promotes early mobilization, and enteral nutrition.
Prior studies which investigated opioid free techniques are based on the combination of drugs acting on sympathetic nervous system, perioperative administration of local anesthetics, nonsteroidal anti-inflammatory drugs, and of adjuvant drugs, such as ketamine, magnesium etc.
Laparoscopic surgery is more challenging in obese patients since they have excessive pneumoperitoneal insufflation pressures, longer anesthetic, surgical, and recovery times. Moreover, these procedures are usually done in Trendelenburg position which further leads to increased airway resistance.
Melatonin is mainly secreted from the pineal gland by the suprachiasmatic nucleus. This neurohormone possesses a circadian secretion pattern and regulates the biological clock; it also offers antiemetic, analgesic, and anxiolytic effects. Due to its effect on both acute and chronic pain, melatonin fulfills a beneficial role in reducing postoperative opioid consumption while minimizing nausea and vomiting. In addition, melatonin can be used to moderate the effect of light on the autonomic system.
Several studies have reported that melatonin, as an analgesic, anti-inflammatory, anxiolytic, and anti-agitation premedication, is associated with sedation and anxiolysis without adverse effects on recall and driving performance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Melatonin group | Active comparator | Drug: MelatoninMelatonin group: A total of 30 obese patients undergoing laparoscopic cholecystectomy will receive melatonin oral (0.2 mg /kg) 45 minutes before general anesthesia. |
| The Control group | Placebo comparator | Dietary Supplement: Vitamin SupplementControl group: A total of 30 obese patients undergoing laparoscopic cholecystectomy will receive placebo medication (Vitamin Supplement) 45 minutes before general anesthesia; Control group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18-45 years.
- Body Mass Index: Over 30 kg/m2.
- Physical Status: ASA classification I and II.
Key exclusion criteria (5 listed)
- Patient refusal.
- Age: Less than 18 years, more than 45 years.
- Patients with known history of allergy towards one of the study drugs.
- Patients with severe cardiac, respiratory, hepatic or renal disease.
- Body Mass Index: Under 30 kg/m2.
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 |
|---|---|---|
| MelatoninAlso: CircadinObese patients undergoing laparoscopic cholecystectomy will receive melatonin oral (0.2 mg /kg) 45 minutes before general anesthesia. | Drug | The Melatonin group |
| Vitamin SupplementObese patients undergoing laparoscopic cholecystectomy will receive placebo medication (Vitamin Supplement) 45 minutes before general anesthesia. | Dietary supplement | The Control group |
Primary outcome
Postoperative Pain.
Time frame: Will be evaluated postoperatively at time of delivery to Post Anesthesia Care Unit (PACU) (Zero time) and every 5 minutes for 30 minutes.
Numeric Rating Scale (NRS); is a pain screening tool, commonly used to assess pain severity at that moment in time using a (0-10) scale, with (0) meaning no pain and (10) meaning the worst pain imaginable.
6 secondary outcomes
Postoperative Pain.
Time frame: Will be evaluated at time of 30 minutes after delivery to PACU and hourly for 4 hours.
Analgesics usage.
Time frame: Will be evaluated postoperatively (Zero time) and every 15 minutes for 1 hour.
Postoperative nausea and vomiting.
Time frame: Will be evaluated postoperatively (Zero time) and every 15 minutes for 1 hour.
Recovery time.
Time frame: Will be evaluated at time of admission to PACU and every 15 minutes for 1 hour until being discharged from it.
Number of participants with hemodynamic instability.
Time frame: Will be evaluated at the start of the operation and every 5 minutes throughout the operation until delivery to PACU and every 15 minutes for 1 hour until being discharged from it.
Number of participants with hemodynamic instability.
Time frame: Will be evaluated at the start of the operation and every 5 minutes throughout the operation until delivery to PACU and every 15 minutes for 1 hour until being discharged from it.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
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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. This study is not recruiting at the moment.
Hala GO Salama, MD principal investigator
Faculty of Medicine, Ain Shams University
Reham MU Hashim, MD principal investigator
Faculty of Medicine, Ain Shams University
Walid YO Youssef, MD principal investigator
Faculty of Medicine, Ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin and Vitamin Supplement in people with Anesthesia, run by Ain Shams University.
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 5 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: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ismail FA Ibrahim, MSc (00201008092950, ismail.mahmoud@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain. (time frame: Will be evaluated postoperatively at time of delivery to Post Anesthesia Care Unit (PACU) (Zero time) and every 5 minutes for 30 minutes.). 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 9 Apr 2024.