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

NCT06739460 | Enrolling By Invitation

• 1 other identifier: AEŞH-EK1-2024-0056
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hysteroscopy

Keywords

Magnesium; Sedation; Hysteroscopi; Opioid; Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  During the hysteroscopic procedures.

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients receiving sedation for gynecological hysteroscopic surgery in the gynecology operating room of Ankara Etlik City Hospital

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• SULEYMAN SARI: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

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

  PMID: 32718032 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 18, 2024
• Study Start: December 10, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 15, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

TU (1)