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Not yet recruiting NCT07330375

Effect of Intravenous Dexmedetomidine and Ketamine on Post-Operative Analgesia

Phase III Interventional Postoperative Analgesia Postoperative Pain Management

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
The protocol lists: Dexmedetomidine, Ketamine, Saline (0.9% NaCl).
Who it may be relevant to
Registry conditions: Postoperative Analgesia, Postoperative Pain Management. Basic parameters: 21 years — 65 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
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effect of Intravenous Combination Dexmedetomidine - Ketamine Versus Dexmedetomidine on Post-Operative Analgesia in Patients Undergoing Vaginal Hysterectomy Under Spinal Anesthesia

Overview

In this study the participants aim to Compare The Effect of Intravenous Combination Dexmedetomidine \_ Ketamine versus Dexmedetomidine on Post-Operative Analgesia In Vaginal Hysterectomy Proceeded Under Spinal Anesthesia regarding efficacy, hamemodynamic stability, outcomes and adverse effects.

Interventions

  • Drug Dexmedetomidine
    Intravenous dexmedetomidine 0.5 µg/kg diluted with normal saline to a volume of 10 ml solution over 10 min followed by 0.5 µg/kg/h infusion.
  • Drug Ketamine
    Intravenous ketamine 0.2 mg/kg diluted with normal saline to a volume of 10 ml solution over 2-3 min followed by 0.2 mg/kg/hr infusion.
  • Drug Saline (0.9% NaCl)
    intravenous normal saline 10ml of solution over 2-3min followed by 0.2 mg/kg/hr infusion as placebo

Primary outcome measures

  • Assess the postoperative analgesic requirements in first 24 hours. [Time frame: Pain grade of patients will be evaluated immediately on arrival to PACU then at 2, 4, 6,12, 24 hours postoperatively]
Secondary outcome measures (1)
  • Total amount of rescue analgesic requirement [Time frame: In first 24 hours postoperatively]

Eligibility criteria

Inclusion criteria

  • Patients who will accept written informed consent.
  • Age: 21-65 years old.
  • Sex: female.
  • BMI: <35 kg/m2
  • Physical status: American Society of Anesthesiology (ASA) of Grade I-II
  • Type of operation: vaginal hysterectomy under spinal anesthesia.

Exclusion criteria

  • Uncooperative patients
  • Any contraindication for spinal anesthesia e.g. coagulopathy, infection at site of block, and hypersensitivity to any drug used in this study.
  • Patients who are known to be drug dependent.

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

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Pandya MJ, Shah A. Comparative evaluation of dexmedetomidine and ketamine for epidural analgesia in lower limb orthopedic surgeries [Internet]. Indian J Clin Anaesth. 2020 [cited 2025 Dec 29];7(1):166-171. Available from: https://doi.org/10.18231/j.ijca.2020.029
  • Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29. PMID 22290456
  • Moawad NS, Santamaria Flores E, Le-Wendling L, Sumner MT, Enneking FK. Total Laparoscopic Hysterectomy Under Regional Anesthesia. Obstet Gynecol. 2018 Jun;131(6):1008-1010. doi: 10.1097/AOG.0000000000002618. PMID 29742667
  • DOI: 10.33545/26643766.2021.v4.i3a.280
  • DOI: 10.9734/jpri/2022/v34i43A36310
  • Krishna AS, Agarwal J, Khanuja S, Kumar S, Khan A, Butt KM. Comparison of intravenous dexmedetomidine versus ketamine-dexmedetomidine combination on spinal block characteristics in patients undergoing lower limb orthopaedic surgery - A randomised clinical trial. Indian J Anaesth. 2024 Sep;68(9):795-800. doi: 10.4103/ija.ija_14_24. Epub 2024 Aug 16. PMID 39386403
  • Blaudszun G, Lysakowski C, Elia N, Tramer MR. Effect of perioperative systemic alpha2 agonists on postoperative morphine consumption and pain intensity: systematic review and meta-analysis of randomized controlled trials. Anesthesiology. 2012 Jun;116(6):1312-22. doi: 10.1097/ALN.0b013e31825681cb. PMID 22546966

Identifiers

NCT: NCT07330375 · 1088

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗