Effect of Intravenous Dexmedetomidine and Ketamine on Post-Operative Analgesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-20

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Postoperative Analgesia Postoperative Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type 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

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Dexmedetomidine

Intervention Type 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.

Saline (0.9% NaCl)

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Saline (0.9% NaCl)

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes