Postoperative PainEarly Phase 1NCT04959825
The Role of Preoperative Melatonin in Reducing the Inhaled Isoflurane Requirements in Open Nephrectomy
A Early Phase 1 study testing Melatonin 5 mg and Sugar Coated Tablets in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Melatonin is a hormone that the pineal gland in the brain produces. Melatonin fulfills many functions in the body but it is mostly known for maintaining a circadian rhythm that is governed by the central circadian pacemaker (biological clock) in the suprachiasmatic nuclei in the hypothalamus. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Melatonin 5 mg and Sugar Coated Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2021to 15 May 2022
- Phase
- Early Phase 1
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing nephrectomy under general anesthesia aged from 20 to 60 years.
- ASA 1 or 2.
- BMI 25 to 30
Who cannot join
- Patients with uncontrolled hypertension.
- Patients presenting with (IHD, significant arrhythmias, heart failure).
- Allergy to melatonin.
- History of epileptic seizures, psychoactive medications, neurological disorders or trauma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Melatonin in Inhaled Anesthetic Consumption
Melatonin is a hormone that the pineal gland in the brain produces. Melatonin fulfills many functions in the body but it is mostly known for maintaining a circadian rhythm that is governed by the central circadian pacemaker (biological clock) in the suprachiasmatic nuclei in the hypothalamus. Melatonin works by attaching to receptors or nerve endings in the suprachiasmatic nucleus (SCN) in the hypothalamus. It binds to melatonin receptor 1 and melatonin receptor 2, commonly referred to as MT1 and MT2. People can take it as a natural or synthetic supplement to promote restful sleep. Melatonin showed promise for preventing shifts in sleep and wake times in people with jetlag and improving sleep in people with insomnia. It can also be used for headaches, cancer, and Alzheimer's disease.
Melatonin can be used as an analgesic, sedative, and hypnotic drug that can distinguish it as an attractive alternative premedicant
Read the detailed description
A study that was done before in J Anaesth by Borazan H et al revealed that postoperative pain score in patients undergoing radical prostatectomy who received melatonin one hour before surgery as a premedication was significantly lower than the control group with a significant P-value( less than 0.05).
The entropy is indicated for adult and pediatric patients older than 2 years intraoperatively for monitoring the electric state of the brain. In adult patients, state entropy and response entropy can be used as an aid in monitoring the effects of certain anaesthetic agents which will help the user to titrate the anaesthetic agent according to the individual needs of each patient.
Furthermore, the use of entropy parameters may be associated with a reduction of anaesthetic use and faster emergence of anaesthesia. The entropy measurement is to be used as an adjunct to other physiological parameters.
To the best of investigators knowledge, there is no study that examined the effect of melatonin on inhaled isoflurane requirements intraoperatively. So, in this study, the effect of melatonin will be assessed on intraoperative inhaled isoflurane requirements in patients undergoing open nephrectomy under general anaesthesia by using entropy
- Conditions
- Postoperative Pain
- Being tested
- Melatonin 5 mg, Sugar Coated Tablets
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 5 mgDrug
study the effect of preoperative oral melatonin 5mg on isoflurane consumption and postoperative pain
Sugar Coated TabletsDrug
the control group patients will receive placebo tablets one hour before induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| melatonin group | Active comparator | Melatonin group (group M )will receive melatonin as a premedication 1 hour before surgery in a dose of 5 mg Receives: Drug: Melatonin 5 mg |
| control group | Placebo comparator | 15 patients will be enrolled for open nephrectomy will receive sugar-coated tablets. Control group(group C) Receives: Drug: Sugar Coated Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhaled isoflurane requirement (volume%) to maintain entropy readings 40-60
Inhaled Isoflurane requirement (volume %) will be titrated to maintain state entropy (SE) and response entropy (RE) readings 40-60 measured using GE carestation 650-crescent pulse anaesthesia machine(6).
Measured: 2 hours
Secondary outcomes (2)
Total morphine consumption over 24 hours postoperative
Measured: 24 hours
Total intraoperative fentanyl consumption
The sum of fentanyl top up doses will be recorded
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start15 Jul 2021
- Primary completion10 Apr 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Hassan Saleh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959825
- Sponsor's protocol ID
- MD-249-2020
- Status last verified
- Jul 2022
- First submitted
- 2 Jul 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Melatonin in Inhaled Anesthetic Consumption
- ClinicalTrials.gov ID
- NCT04959825
- Acronym / sponsor ID
- MD-249-2020
- Conditions
- Postoperative Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 10 Apr 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 13 Jul 2021 (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.
Melatonin is a hormone that the pineal gland in the brain produces. Melatonin fulfills many functions in the body but it is mostly known for maintaining a circadian rhythm that is governed by the central circadian pacemaker (biological clock) in the suprachiasmatic nuclei in the hypothalamus. Melatonin works by attaching to receptors or nerve endings in the suprachiasmatic nucleus (SCN) in the hypothalamus. It binds to melatonin receptor 1 and melatonin receptor 2, commonly referred to as MT1 and MT2. People can take it as a natural or synthetic supplement to promote restful sleep. Melatonin showed promise for preventing shifts in sleep and wake times in people with jetlag and improving sleep in people with insomnia. It can also be used for headaches, cancer, and Alzheimer's disease.
Melatonin can be used as an analgesic, sedative, and hypnotic drug that can distinguish it as an attractive alternative premedicant
Detailed description
A study that was done before in J Anaesth by Borazan H et al revealed that postoperative pain score in patients undergoing radical prostatectomy who received melatonin one hour before surgery as a premedication was significantly lower than the control group with a significant P-value( less than 0.05).
The entropy is indicated for adult and pediatric patients older than 2 years intraoperatively for monitoring the electric state of the brain. In adult patients, state entropy and response entropy can be used as an aid in monitoring the effects of certain anaesthetic agents which will help the user to titrate the anaesthetic agent according to the individual needs of each patient.
Furthermore, the use of entropy parameters may be associated with a reduction of anaesthetic use and faster emergence of anaesthesia. The entropy measurement is to be used as an adjunct to other physiological parameters.
To the best of investigators knowledge, there is no study that examined the effect of melatonin on inhaled isoflurane requirements intraoperatively. So, in this study, the effect of melatonin will be assessed on intraoperative inhaled isoflurane requirements in patients undergoing open nephrectomy under general anaesthesia by using entropy
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| melatonin group | Active comparator | Drug: Melatonin 5 mgMelatonin group (group M )will receive melatonin as a premedication 1 hour before surgery in a dose of 5 mg |
| control group | Placebo comparator | Drug: Sugar Coated Tablets15 patients will be enrolled for open nephrectomy will receive sugar-coated tablets. Control group(group C) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients undergoing nephrectomy under general anesthesia aged from 20 to 60 years.
- ASA 1 or 2.
- BMI 25 to 30
Key exclusion criteria (4 listed)
- Patients with uncontrolled hypertension.
- Patients presenting with (IHD, significant arrhythmias, heart failure).
- Allergy to melatonin.
- History of epileptic seizures, psychoactive medications, neurological disorders or trauma.
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 |
|---|---|---|
| Melatonin 5 mgstudy the effect of preoperative oral melatonin 5mg on isoflurane consumption and postoperative pain | Drug | melatonin group |
| Sugar Coated Tabletsthe control group patients will receive placebo tablets one hour before induction of anesthesia | Drug | control group |
Primary outcome
Inhaled isoflurane requirement (volume%) to maintain entropy readings 40-60
Time frame: 2 hours
Inhaled Isoflurane requirement (volume %) will be titrated to maintain state entropy (SE) and response entropy (RE) readings 40-60 measured using GE carestation 650-crescent pulse anaesthesia machine(6).
2 secondary outcomes
Total morphine consumption over 24 hours postoperative
Time frame: 24 hours
Total intraoperative fentanyl consumption
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Melatonin 5 mg and Sugar Coated Tablets in people with Postoperative Pain, run by Cairo 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 4 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: finished, as of the sponsor's last update on 20 Jul 2022. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhaled isoflurane requirement (volume%) to maintain entropy readings 40-60 (time frame: 2 hours). 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 20 Jul 2022.