Effect of Intravenous Dexmedetomidine and Ketamine on Post-Operative Analgesia

NCT07330375 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 1088
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Analgesia; Postoperative Pain Management

Keywords

spinal anesthesia; vaginal hysterectomy; dexmedetomidine; ketamine

Outcome Measures

Primary Outcomes (1)

• Assess the postoperative analgesic requirements in first 24 hours.

  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 Outcomes (1)

• Total amount of rescue analgesic requirement

  In first 24 hours postoperatively

Study Arms (2)

Group D+K (Dexmedetomidine-Ketamine Combination)

ACTIVE COMPARATOR

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; Drug: Ketamine

Dexmedetomidine group (D)

PLACEBO COMPARATOR

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; Drug: Saline (0.9% NaCl)

Interventions

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.

Dexmedetomidine group (D); Group D+K (Dexmedetomidine-Ketamine Combination)

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.

Group D+K (Dexmedetomidine-Ketamine Combination)

Saline (0.9% NaCl) DRUG

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

Dexmedetomidine group (D)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Gender Eligibility Details: female aged b/w 21-65 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Related Publications (7)

• 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

  RESULT

• 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 RESULT

• 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 RESULT

• DOI: 10.33545/26643766.2021.v4.i3a.280

  RESULT

• DOI: 10.9734/jpri/2022/v34i43A36310

  RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Ketamine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Abdelrahman Elsayed Amer, Resident of Anesthesia

CONTACT

00201024172506; ae.amer025@medicine.zu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the drugs will be prepared by anesthesiologist who will not be the part of the study and these drugs will be injected by another anesthesiologist who will be blinded to the drugs and will be participating into the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Intensive Care and Pain management

Model Details: Patients will be randomly assigned to either group Dexmedetomidine-ketamine combination (receiving I/V of dexmedetomidine 0.5 µg/kg over 10 min ,followed by 0.5 µg/kg/hr infusion and receiving I/V of ketamine 0.2mg/kg over 2-3min ,followed by 0.2 mg/kg/hr infusion ) OR group Dexmedetomidine (receiving I/V of dexmedetomidine 0.5 µg/kg over 10 min ,followed by 0.5 µg/kg/hr infusion and receiving I/V of normal saline ) through sequentially numbered opaque sealed envelope. Anesthesiologist and patients both will be blinded to the administered drug in two groups. Either of the drugs will be injected after giving spinal anesthesia and confirmation of achievement of desired level of block. In both groups, Dexmedetomidine will titrate 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 Dexmedetomidine, both drug infusions were stopped.The drug infusions were restarted at the lowest doses at RSS of 3.

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 9, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: planned after the completion of the study and publication
• Access Criteria: principal investigator