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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of rescue analgesic requirement | Total amount of rescue analgesic requirement in first 24 hours Postoperatively | In first 24 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
female aged b/w 21-65 years
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdelrahman Elsayed Amer, Resident of Anesthesia | Contact | 00201024172506 | ae.amer025@medicine.zu.edu.eg |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 | ||
| 22290456 | 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. | |
| 29742667 |
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planned after the completion of the study and publication
planned after the completion of the study and publication
principal investigator
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D007649 | Ketamine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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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.
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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.
| 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 |
|
| 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. |
| Result | DOI: 10.33545/26643766.2021.v4.i3a.280 |
| Result | DOI: 10.9734/jpri/2022/v34i43A36310 |
| 39386403 | 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. |
| 22546966 | 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. |
| D003510 |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |