Postoperative Analgesia, Postoperative Pain Management
Conditions
Keywords
spinal anesthesia, vaginal hysterectomy, dexmedetomidine, ketamine
Brief summary
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.
Interventions
DRUGDexmedetomidine
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.
DRUGKetamine
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.
DRUGSaline (0.9% NaCl)
intravenous normal saline 10ml of solution over 2-3min followed by 0.2 mg/kg/hr infusion as placebo
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the postoperative analgesic requirements in first 24 hours. | 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 . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total amount of rescue analgesic requirement | In first 24 hours postoperatively | Total amount of rescue analgesic requirement in first 24 hours Postoperatively |
Contacts
Primary ContactAbdelrahman Elsayed Amer, Resident of Anesthesia
Outcome results
None listed