Health TrialsbyHealthPanel

Effect of Intravenous Dexmedetomidine and Ketamine on Post-Operative Analgesia

ConditionsPostoperative AnalgesiaPostoperative Pain Management
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age21-65
SponsorZagazig University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients who will accept written informed consent.

Age: 21-65 years old.

Sex: female.

BMI: <35 kg/m2

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group D+K (Dexmedetomidine-Ketamine Combination)Active comparator 2 interventions
Group B: Dexmedetomidine group (D)Placebo comparator 2 interventions

Trial outcomes

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 .

Time frame
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

Total amount of rescue analgesic requirement in first 24 hours Postoperatively

Time frame
In first 24 hours postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zagazig University

Lead sponsor

Source ClinicalTrials.gov

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