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Enrolling by invitation NCT06739460

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

Observational Hysteroscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hysteroscopy. Basic parameters: 18 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Antinociceptive effects of ketamine and magnesium [Time frame: During the hysteroscopic procedures.]

Eligibility criteria

Inclusion criteria

  • ASA I-II patients
  • Patients aged 18-55
  • Patients undergoing hysteroscopy

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Etlik City Hospital — Ankara

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. PMID 12393361
  • 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. PMID 32957926
  • Shin HJ, Na HS, Do SH. Magnesium and Pain. Nutrients. 2020 Jul 23;12(8):2184. doi: 10.3390/nu12082184. PMID 32718032

Identifiers

NCT: NCT06739460 · AEŞH-EK1-2024-0056

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗