Effect of Intravenous Dexmedetomidine and Ketamine on Post-Operative Analgesia

December 28, 2025 updated by: abdelrahman elsayed abdelrahman elsayed saad amer, Zagazig University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group D+K (Dexmedetomidine-Ketamine Combination)

Patients will receive intravenous dexmedetomidine (drug 1) loading dose of 0.5 µg/kg diluted with normal saline to a volume of 10 ml solution over 10 min (started when a sensory level of T10 was achieved) Maintenance dose of 0.5 µg/kg/h infusion and Intravenous ketamine (drug 2) loading dose of 0.2mg/kg diluted with normal saline to a volume of 10 ml solution over 2-3min ( started when a sensory level of T10 was achieved) maintenance dose of 0.2 mg/kg/h infusion.

In both groups, drug 1 will be titrated by 0.1 µg/kg/h every 30 min to maintain a Ramsay Sedation Scale (RSS) score of 3-4.

If the RSS score was >4 at 0.2 µg/kg/h of Drug 1, both drug infusions will be stopped.The drug infusions will be restarted at the lowest doses at RSS of 3.
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.
Placebo Comparator: Dexmedetomidine group (D)

Patients will receive intravenous dexmedetomidine (drug 1) loading dose of 0.5 µg/kg diluted with normal saline to a volume of10 ml solution over 10 min (started when a sensory level of T10 was achieved) Maintenance dose of 0.5 µg/kg/h and intravenous normal saline (drug 2) loading dose 10ml of solution over 2-3min ( started when a sensory level of T10 was achieved) and a maintenance dose of 0.2 mg/kg/h as placebo.

In both groups, drug 1 will be titrated by 0.1 µg/kg/h every 30 min to maintain a Ramsay Sedation Scale (RSS) score of 3-4. If the RSS score >4 at 0.2 µg/kg/h of Drug 1, both drug infusions will be stopped.The drug infusions will be restarted at the lowest doses at RSS of 3.
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: Saline (0.9% NaCl)
intravenous normal saline 10ml of solution over 2-3min followed by 0.2 mg/kg/hr infusion as placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
Pain grade of patients will be evaluated immediately on arrival to PACU then at 2, 4, 6,12, 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total amount of rescue analgesic requirement
Time Frame: In first 24 hours postoperatively
Total amount of rescue analgesic requirement in first 24 hours Postoperatively
In first 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 20, 2026

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 28, 2025

First Submitted That Met QC Criteria

December 28, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

December 28, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

planned after the completion of the study and publication

IPD Sharing Time Frame

planned after the completion of the study and publication

IPD Sharing Access Criteria

principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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