Effect of Intravenous Dexmedetomidine and Ketamine on Post-Operative Analgesia

Zagazig University

Status and phase: Not yet enrolling; Phase 3

Conditions: Postoperative Analgesia; Postoperative Pain Management

Treatments: Drug: Ketamine; Drug: Dexmedetomidine; Drug: Saline (0.9% NaCl)

Study type: Interventional

Funder types: Other

Identifiers

NCT07330375

1088

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Group D+K (Dexmedetomidine-Ketamine Combination)

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Drug: Ketamine

Dexmedetomidine group (D)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline (0.9% NaCl)

Drug: Dexmedetomidine