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Comparison of Antinociceptive Effects of Ketamine and Magnesium Used for Sedation in Hysteroscopy Cases

NCT ID: NCT06739460

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-10

Study Completion Date

2025-01-15

Brief Summary

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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

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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

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Hysteroscopy

Keywords

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Magnesium Sedation Hysteroscopi Opioid Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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P group

This group consists of hysteroscopy cases in which sedation was given using fentanyl, midazolam, propofol and remifentanil.

No interventions assigned to this group

K group

This group consists of hysteroscopy cases in which sedation was given using fentanyl, midazolam, ketamine, propofol and remifentanil.

No interventions assigned to this group

KM group

This group consists of hysteroscopy cases that received preoperative magnesium sulfate and sedation using fentanyl, midazolam, ketamine, propofol and remifentanil.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. ASA I-II patients
2. Patients aged 18-55
3. Patients undergoing hysteroscopy

Exclusion Criteria

1. Patients who develop surgical complications during hysteroscopy
2. Patients with cardiovascular failure (ejection fraction \<40%, patients with atrioventricular conduction disorder
3. Patients with history of cerebrovascular disease
4. Liver dysfunction (transaminases above normal level), Renal failure (creatine \> 150 μmol/L),
5. Preoperative opioid use
6. History of neuromuscular disease
7. History of drug or alcohol abuse
8. Patients who develop the need for endotracheal intubation
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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SULEYMAN SARI

OTHER_GOV

Sponsor Role lead

Responsible Party

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SULEYMAN SARI

Attending Physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ankara Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 12393361 (View on PubMed)

Gao 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.

Reference Type BACKGROUND
PMID: 32957926 (View on PubMed)

Shin HJ, Na HS, Do SH. Magnesium and Pain. Nutrients. 2020 Jul 23;12(8):2184. doi: 10.3390/nu12082184.

Reference Type BACKGROUND
PMID: 32718032 (View on PubMed)

Other Identifiers

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AEŞH-EK1-2024-0056

Identifier Type: -

Identifier Source: org_study_id