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NCT Number: NCT07330375

Effect of Intravenous Dexmedetomidine and Ketamine on Post-Operative Analgesia

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.

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Key information

Conditions

Postoperative Analgesia Postoperative Pain Management

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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.

ketamine

Drug

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.

Saline (0.9% NaCl)

Drug

intravenous normal saline 10ml of solution over 2-3min followed by 0.2 mg/kg/hr infusion as placebo

Primary outcomes

  1. 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

    Pain will be assessed and recorded using visual analogue scale (VAS) {0=no pain, 1 to 3 = mild pain, 4 to 6 = moderate pain, 7 to 10 = severe pain} immediately on arrival to PACU then at 2, 4, 6,12, 24 hours after surgery by an observer blinded to treatment groups. • On the first analgesic demand or when VAS scale 1-3, diclofenac 75 mg IV will be given. nalbupine 20 mg IV will be administered as a rescue analgesic, as needed if the VAS scale 4-10 .

Secondary outcomes

  1. Total amount of rescue analgesic requirement

    Time frame: In first 24 hours postoperatively

    Total amount of rescue analgesic requirement in first 24 hours Postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelrahman Elsayed Amer, Resident of Anesthesia

CONTACT

[email protected]

00201024172506

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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