HysteroscopyNCT06739460
Comparison of Antinociceptive Effects of Ketamine and Magnesium Used for Sedation in Hysteroscopy Cases
An observational study of Hysteroscopy, run by SULEYMAN SARI at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the antinociceptive effects of ketamine and magnesium used in addition to midazolam, fentanyl, propofol and remifentanil agents preferred in hysteroscopy cases. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Hysteroscopy
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2024to 15 Jan 2025
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients receiving sedation for gynecological hysteroscopic surgery in the gynecology operating room of Ankara Etlik City Hospital
Who may be able to join
- ASA I-II patients
- Patients aged 18-55
- Patients undergoing hysteroscopy
Who cannot join
- Patients who develop surgical complications during hysteroscopy
- Patients with cardiovascular failure (ejection fraction <40%, patients with atrioventricular conduction disorder
- Patients with history of cerebrovascular disease
- Liver dysfunction (transaminases above normal level), Renal failure (creatine > 150 μmol/L),
- Preoperative opioid use
- History of neuromuscular disease
- History of drug or alcohol abuse
- Patients who develop the need for endotracheal intubation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06170
About this study
This study aims to compare the antinociceptive effects of ketamine and magnesium used in addition to midazolam, fentanyl, propofol and remifentanil agents preferred in hysteroscopy cases. It is conducted to observe the effect of ketamine and magnesium use on total additional propofol doses and additional remifentanil doses.
Read the detailed description
Sedation is generally preferred in hysteroscopy cases. The most commonly used intravenous drugs are midazolam, fentanyl, propofol and remifentanil. Multimodal analgesia, which is intended to be provided in hysteroscopy cases, is a strategy that includes the use of two or more analgesic agents and techniques to provide adequate analgesia; and aims to minimize side effects such as bradycardia, hypotension, respiratory depression, pruritus, and postoperative nausea and vomiting. Multimodal analgesia improves patient and surgical comfort by applying additional drugs to existing agents, reduces postoperative complications, and thus helps to shorten hospital stays and reduce costs. Whether magnesium contributes to this multimodal analgesia will be investigated observationally, based on its antinociceptive effects.
- Conditions
- Hysteroscopy
- Keywords
- Magnesium, Sedation, Hysteroscopi, Opioid, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| P group | This group consists of hysteroscopy cases in which sedation was given using fentanyl, midazolam, propofol and remifentanil. | |
| K group | This group consists of hysteroscopy cases in which sedation was given using fentanyl, midazolam, ketamine, propofol and remifentanil. | |
| KM group | This group consists of hysteroscopy cases that received preoperative magnesium sulfate and sedation using fentanyl, midazolam, ketamine, propofol and remifentanil. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antinociceptive effects of ketamine and magnesium
Observe the effect of ketamine and magnesium use on total additional doses of propofol and additional doses of remifentanil.
Measured: During the hysteroscopic procedures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start10 Dec 2024 (estimated)
- Primary completion10 Jan 2025 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HysteroscopyStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- SULEYMAN SARI
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, SULEYMAN SARI, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739460
- Sponsor's protocol ID
- AEŞH-EK1-2024-0056
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Telci L, Esen F, Akcora D, Erden T, Canbolat AT, Akpir K. Evaluation of effects of magnesium sulphate in reducing intraoperative anaesthetic requirements. Br J Anaesth. 2002 Oct;89(4):594-8. doi: 10.1093/bja/aef238.
PubMed 12393361Gao PF, Lin JY, Wang S, Zhang YF, Wang GQ, Xu Q, Guo X. Antinociceptive effects of magnesium sulfate for monitored anesthesia care during hysteroscopy: a randomized controlled study. BMC Anesthesiol. 2020 Sep 21;20(1):240. doi: 10.1186/s12871-020-01158-9.
PubMed 32957926Shin HJ, Na HS, Do SH. Magnesium and Pain. Nutrients. 2020 Jul 23;12(8):2184. doi: 10.3390/nu12082184.
PubMed 32718032
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Antinociceptive Effects of Ketamine and Magnesium Used for Sedation in Hysteroscopy Cases
- ClinicalTrials.gov ID
- NCT06739460
- Acronym / sponsor ID
- AEŞH-EK1-2024-0056
- Conditions
- Hysteroscopy
- Keywords
- Magnesium, Sedation, Hysteroscopi, Opioid, Pain
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- SULEYMAN SARIOther government
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 18 Dec 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.
This study aims to compare the antinociceptive effects of ketamine and magnesium used in addition to midazolam, fentanyl, propofol and remifentanil agents preferred in hysteroscopy cases. It is conducted to observe the effect of ketamine and magnesium use on total additional propofol doses and additional remifentanil doses.
Detailed description
Sedation is generally preferred in hysteroscopy cases. The most commonly used intravenous drugs are midazolam, fentanyl, propofol and remifentanil. Multimodal analgesia, which is intended to be provided in hysteroscopy cases, is a strategy that includes the use of two or more analgesic agents and techniques to provide adequate analgesia; and aims to minimize side effects such as bradycardia, hypotension, respiratory depression, pruritus, and postoperative nausea and vomiting. Multimodal analgesia improves patient and surgical comfort by applying additional drugs to existing agents, reduces postoperative complications, and thus helps to shorten hospital stays and reduce costs. Whether magnesium contributes to this multimodal analgesia will be investigated observationally, based on its antinociceptive effects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| P group | – | –This group consists of hysteroscopy cases in which sedation was given using fentanyl, midazolam, propofol and remifentanil. |
| K group | – | –This group consists of hysteroscopy cases in which sedation was given using fentanyl, midazolam, ketamine, propofol and remifentanil. |
| KM group | – | –This group consists of hysteroscopy cases that received preoperative magnesium sulfate and sedation using fentanyl, midazolam, ketamine, propofol and remifentanil. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients receiving sedation for gynecological hysteroscopic surgery in the gynecology operating room of Ankara Etlik City Hospital
Key inclusion criteria (3 listed)
- ASA I-II patients
- Patients aged 18-55
- Patients undergoing hysteroscopy
Key exclusion criteria (8 listed)
- Patients who develop surgical complications during hysteroscopy
- Patients with cardiovascular failure (ejection fraction <40%, patients with atrioventricular conduction disorder
- Patients with history of cerebrovascular disease
- Liver dysfunction (transaminases above normal level), Renal failure (creatine > 150 μmol/L),
- Preoperative opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Antinociceptive effects of ketamine and magnesium
Time frame: During the hysteroscopic procedures.
Observe the effect of ketamine and magnesium use on total additional doses of propofol and additional doses of remifentanil.
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 18 Dec 2024.
- Background: PubMed 12393361Telci L, Esen F, Akcora D, Erden T, Canbolat AT, Akpir K. Evaluation of effects of magnesium sulphate in reducing intraoperative anaesthetic requirements. Br J Anaesth. 2002 Oct;89(4):594-8. doi: 10.1093/bja/aef238.
- Background: PubMed 32957926Gao PF, Lin JY, Wang S, Zhang YF, Wang GQ, Xu Q, Guo X. Antinociceptive effects of magnesium sulfate for monitored anesthesia care during hysteroscopy: a randomized controlled study. BMC Anesthesiol. 2020 Sep 21;20(1):240. doi: 10.1186/s12871-020-01158-9.
- Background: PubMed 32718032Shin HJ, Na HS, Do SH. Magnesium and Pain. Nutrients. 2020 Jul 23;12(8):2184. doi: 10.3390/nu12082184.
- Individual participant dataSharing planned: Yes
Related trials for Hysteroscopy
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
Enrolling by invitationPhase 1
Combined Ketorolac and Lidocaine Paracervical Block for Office Hysteroscopy
Abnormal Uterine Bleeding, Analgesia
RecruitingObservational study
Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions
Pregnancy Complicated With Intrauterine Adhesion
Recruiting
Office Hysteroscopy in Postmenopausal Women: A Randomized Trial of Cervical Preparation Strategies
Postmenopausal Women, Intrauterine Diseases
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
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.
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?
An observational study of Hysteroscopy, run by SULEYMAN SARI 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 3 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 18 Dec 2024. 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?
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?
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?
Antinociceptive effects of ketamine and magnesium (time frame: During the hysteroscopic procedures.). 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 NCT06739460, which also lists 3 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 18 Dec 2024.