Clinical trial NCT06739460: Comparison of Antinociceptive Effects of Ketamine and Magnesium Used for Sedation in Hysteroscopy Cases
Official title: Comparison of Antinociceptive Effects of Ketamine and Magnesium Used for Sedation in Hysteroscopy Cases
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hysteroscopy
Keywords: Magnesium
Sedation
Hysteroscopi
Opioid
Pain
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-12-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving sedation for gynecological hysteroscopic surgery in the gynecology operating room of Ankara Etlik City Hospital

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Antinociceptive effects of ketamine and magnesium
timeFrame: During the hysteroscopic procedures.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Yenimahalle
Study officials:
References:
citation: 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.
citation: 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.
citation: Shin HJ, Na HS, Do SH. Magnesium and Pain. Nutrients. 2020 Jul 23;12(8):2184. doi: 10.3390/nu12082184.