Bariatric SurgeryNCT03107702
Melatonin Level and Postoperative Analgesia Consumption in Bariatric Surgery Patients.
An observational study of Bariatric Surgery and Melatonin, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Bariatric surgical procedures are associated with low short-term mortality and may be associated with long-term reductions in all-cause, cardiovascular, and cancer-related mortality. This surgeries are major surgeries include risk of mortality still. Melatonin is a hormone secreted from the pineal gland. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery, Melatonin, POSTOPERATIVE PAIN
- What is being tested?
- melatonin
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Mar 2017to 30 Jul 2017
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients of American Society of Anesthesiologists (ASA) 1-2 status, aged between 18-65 years who are scheduled to undergo bariatric surgery.
Who may be able to join
- American Society of Anesthesiologists (ASA) 3-4 status, aged between 18-65 years who are scheduled to undergo bariatric surgery.
Who cannot join
- Patients with cardiovascular and pulmonary disease, those with ASA III-IV and propofol, fentanyl, remifentanil and rocuronium allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Melatonin Level and Postoperative Analgesia Consumption in Bariatric Surgery Patients.
Bariatric surgical procedures are associated with low short-term mortality and may be associated with long-term reductions in all-cause, cardiovascular, and cancer-related mortality. This surgeries are major surgeries include risk of mortality still.
Melatonin is a hormone secreted from the pineal gland. Melatonin is an antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative and analgesic. Melatonin is neurohormone with the profile of a novel hypnotic-anesthetic agent.
The purpose of this study is to investigate the preoperative, perioperative and postoperative melatonin levels in bariatric surgery under general anesthesia and to investigate the relationship between melatonin level and analgesia requirement.
Read the detailed description
Bariatric surgical procedures are associated with low short-term mortality and may be associated with long-term reductions in all-cause, cardiovascular, and cancer-related mortality. This surgeries are major surgeries include risk of mortality still.
Melatonin is a hormone secreted from the pineal gland. Melatonin is an antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative and analgesic. Irregularity of melatonin secretion causes a sleep irregularities, psychosis in intensive care unit and some behavioral disorder. The hypnotic, antinociceptive, and anticonvulsant properties of melatonin endow this neurohormone with the profile of a novel hypnotic-anesthetic agent.
The purpose of this study is to investigate the preoperative, perioperative and postoperative melatonin levels in bariatric surgery under general anesthesia and to investigate the relationship between melatonin level and analgesia requirement.
- Conditions
- Bariatric Surgery, Melatonin, POSTOPERATIVE PAIN
- Being tested
- melatonin
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melatoninDiagnostic test
the relationship between melatonin level and analgesia requirement.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin and bariatric surgery | the relationship between melatonin level and analgesia requirement. Receives: Diagnostic Test: melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melatonin Level
Melatonin is a hormone secreted from the pineal gland. It shows a daily biorhythm. Melatonin level can be measured in the blood and in urine collected for 24 hours.
Measured: Change from Baseline melatonin at postoperative 24 hours
Secondary outcomes (1)
Morphine consumption
Morphine is analgesic agent. It will used postoperative period
Measured: change from postoperative up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start29 Mar 2017
- Primary completion30 Jun 2017 (estimated)
- Study completion30 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ali Erdoğan, Inonu University
- Investigators
- Türkan Toğal, Prof., Study director, Inonu University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107702
- Sponsor's protocol ID
- MAE5
- Status last verified
- Apr 2017
- First submitted
- 29 Mar 2017
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naguib M, Gottumukkala V, Goldstein PA. Melatonin and anesthesia: a clinical perspective. J Pineal Res. 2007 Jan;42(1):12-21. doi: 10.1111/j.1600-079X.2006.00384.x.
PubMed 17198534Gogenur I, Ocak U, Altunpinar O, Middleton B, Skene DJ, Rosenberg J. Disturbances in melatonin, cortisol and core body temperature rhythms after major surgery. World J Surg. 2007 Feb;31(2):290-8. doi: 10.1007/s00268-006-0256-5.
PubMed 17180564Hansen MV. Chronobiology, cognitive function and depressive symptoms in surgical patients. Dan Med J. 2014 Sep;61(9):B4914.
PubMed 25186550Altunkaya N, Erdogan MA, Ozgul U, Sanli M, Ucar M, Ozhan O, Sumer F, Erdogan S, Colak C, Durmus M. Changes in Melatonin, Cortisol, and Body Temperature, and the Relationship Between Endogenous Melatonin Levels and Analgesia Consumption in Patients Undergoing Bariatric Surgery. Obes Surg. 2018 Oct;28(10):3186-3192. doi: 10.1007/s11695-018-3313-x.
PubMed 29785473
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Melatonin Level and Postoperative Analgesia Consumption in Bariatric Surgery Patients.
- ClinicalTrials.gov ID
- NCT03107702
- Acronym / sponsor ID
- MAE5
- Conditions
- Bariatric Surgery, Melatonin, POSTOPERATIVE PAIN
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 30 Jun 2017 (estimated)
- Study completion
- 30 Jul 2017 (estimated)
- First posted
- 11 Apr 2017 (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.
Bariatric surgical procedures are associated with low short-term mortality and may be associated with long-term reductions in all-cause, cardiovascular, and cancer-related mortality. This surgeries are major surgeries include risk of mortality still.
Melatonin is a hormone secreted from the pineal gland. Melatonin is an antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative and analgesic. Melatonin is neurohormone with the profile of a novel hypnotic-anesthetic agent.
The purpose of this study is to investigate the preoperative, perioperative and postoperative melatonin levels in bariatric surgery under general anesthesia and to investigate the relationship between melatonin level and analgesia requirement.
Detailed description
Bariatric surgical procedures are associated with low short-term mortality and may be associated with long-term reductions in all-cause, cardiovascular, and cancer-related mortality. This surgeries are major surgeries include risk of mortality still.
Melatonin is a hormone secreted from the pineal gland. Melatonin is an antioxidant, antinociceptive, hypnotic, anticonvulsant, neuroprotective, anxiolytic, sedative and analgesic. Irregularity of melatonin secretion causes a sleep irregularities, psychosis in intensive care unit and some behavioral disorder. The hypnotic, antinociceptive, and anticonvulsant properties of melatonin endow this neurohormone with the profile of a novel hypnotic-anesthetic agent.
The purpose of this study is to investigate the preoperative, perioperative and postoperative melatonin levels in bariatric surgery under general anesthesia and to investigate the relationship between melatonin level and analgesia requirement.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melatonin and bariatric surgery | – | Diagnostic Test: melatoninthe relationship between melatonin level and analgesia requirement. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients of American Society of Anesthesiologists (ASA) 1-2 status, aged between 18-65 years who are scheduled to undergo bariatric surgery.
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) 3-4 status, aged between 18-65 years who are scheduled to undergo bariatric surgery.
Key exclusion criteria (1 listed)
- Patients with cardiovascular and pulmonary disease, those with ASA III-IV and propofol, fentanyl, remifentanil and rocuronium allergy.
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 |
|---|---|---|
| melatoninthe relationship between melatonin level and analgesia requirement. | Diagnostic test | Melatonin and bariatric surgery |
Primary outcome
Melatonin Level
Time frame: Change from Baseline melatonin at postoperative 24 hours
Melatonin is a hormone secreted from the pineal gland. It shows a daily biorhythm. Melatonin level can be measured in the blood and in urine collected for 24 hours.
1 secondary outcome
Morphine consumption
Time frame: change from postoperative up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Background: PubMed 17198534Naguib M, Gottumukkala V, Goldstein PA. Melatonin and anesthesia: a clinical perspective. J Pineal Res. 2007 Jan;42(1):12-21. doi: 10.1111/j.1600-079X.2006.00384.x.
- Background: PubMed 17180564Gogenur I, Ocak U, Altunpinar O, Middleton B, Skene DJ, Rosenberg J. Disturbances in melatonin, cortisol and core body temperature rhythms after major surgery. World J Surg. 2007 Feb;31(2):290-8. doi: 10.1007/s00268-006-0256-5.
- Background: PubMed 25186550Hansen MV. Chronobiology, cognitive function and depressive symptoms in surgical patients. Dan Med J. 2014 Sep;61(9):B4914.
- Derived from this study: PubMed 29785473Altunkaya N, Erdogan MA, Ozgul U, Sanli M, Ucar M, Ozhan O, Sumer F, Erdogan S, Colak C, Durmus M. Changes in Melatonin, Cortisol, and Body Temperature, and the Relationship Between Endogenous Melatonin Levels and Analgesia Consumption in Patients Undergoing Bariatric Surgery. Obes Surg. 2018 Oct;28(10):3186-3192. doi: 10.1007/s11695-018-3313-x.
- Individual participant dataSharing planned: No
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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.
Türkan Toğal, Prof. study director
Inonu University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery and Melatonin, run by Inonu University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 11 Apr 2017. 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 Turkey (Türkiye). 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. 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?
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?
Melatonin Level (time frame: Change from Baseline melatonin at postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03107702, which also lists 4 linked publications.
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 11 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.