The Effect of Intravenous Combination Dexmedetomidine - Ketamine Versus Dexmedetomidine on Post-Operative Analgesia in Patients Undergoing Vaginal Hysterectomy Under Spinal Anesthesia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Assess the postoperative analgesic requirements in first 24 hours.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Dexmedetomidine (Drug)
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.
干预措施: Ketamine (Drug)
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.
干预措施: Dexmedetomidine (Drug)
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.
干预措施: Saline (0.9% NaCl) (Drug)
结局指标
主要结局
Assess the postoperative analgesic requirements in first 24 hours.
时间窗: 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 .
次要结局
- Total amount of rescue analgesic requirement(In first 24 hours postoperatively)
研究者
abdelrahman elsayed abdelrahman elsayed saad amer
Resident of Anesthesia, Intensive Care and Pain management
Zagazig University