Shifa International Hospital Islamabad
Islamabad, Federal, 44000, Pakistan
NCT Number: NCT07807020
This study aims to determine whether lower doses (4 µg) of intrathecal dexmedetomidine can provide comparable analgesic benefits while minimizing adverse hemodynamic effects in patients encountered in our setup( Shifa International Hospital Islamabad). Studies conducted earlier in other setups have used hyperbaric 0.5% bupivacaine but this study will use 0.75% bupivacaine.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Phase 1 / Phase 2
Islamabad, Federal, 44000, Pakistan
"Effect of adding low-dose intrathecal dexmedetomidine to hyperbaric bupivacaine on the duration and quality of spinal anesthesia in knee arthroplasty." This study aims to determine whether lower doses (4 µg) of intrathecal dexmedetomidine can provide comparable analgesic benefits while minimizing adverse hemodynamic effects in patients encountered in our setup( Shifa International Hospital Islamabad). Studies conducted earlier in other setups have used hyperbaric 0.5% bupivacaine but this study will use 0.75% bupivacaine.
Objectives Primary Objective To compare the time to first postoperative analgesia request between patients receiving intrathecal 0.75% hyperbaric bupivacaine alone and those receiving intrathecal dexmedetomidine as an adjunct.
Secondary Objectives
Methodology Study design Quasi-experimental, non-randomized controlled design Study setting
Group A: 1.5 mL of 0.75% hyperbaric bupivacaine + 4 µg dexmedetomidine + Normal Saline to make total volume 2.0 mL Group B (Control): 1.5 mL of 0.75% hyperbaric bupivacaine + 0.5 mL Normal Saline to make total volume 2.0 mL Inclusion Criteria
Grouping Method A total of 60 participants will be included in the study. Participants will be allocated into intervention and comparison groups based on the treating physician's clinical judgement.. Group I (intervention group) will consist of participants who will receive dexmedetomidine, while Group II (comparison group) will consist of participants who will not receive the dexmedetomidine.
Drug Preparation and Administration Dexmedetomidine (100 µg/mL) will be drawn using an insulin syringe for accuracy and will be added in 9 ml Normal Saline (Total 10 ml) to make a concentration of 10 µg/mL.
For 4 µg: 0.4 mL dexmedetomidine (10 µg/mL) diluted with normal saline to make 0.5 mL will be prepared in an insulin syringe.
The control group will receive 0.5 mL saline in an insulin syringe. All solutions will be clear and identical, prepared immediately before injection. Each patient will receive a total of 2.0 mL intrathecally at L3-L4 or L4-L5 using a 25G Quincke needle.
Outcome Measures
Primary Outcome:
Secondary Outcomes:
Timeline Total duration: 12 months ( 8 months data collection, 2 months analysis, 2 months reporting).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
• Patients aged between 18 and 60 years
Exclusion criteria
Allergy to study drugs
Group A experimental group: 1.5 mL of 0.75% hyperbaric bupivacaine + 4 µg dexmedetomidine + Normal Saline to make total volume 2.0 mLThis study aims to determine whether lower doses (4 µg) of intrathecal dexmedetomidine can provide comparable analgesic benefits while minimizing adverse hemodynamic effects in patients encountered in our setup( Shifa International Hospital Islamabad). Studies conducted earlier in other setups have used hyperbaric 0.5% bupivacaine but this study will use 0.75% bupivacaine
Other names: precidex
Group B (Control): 1.5 mL of 0.75% hyperbaric bupivacaine + 0.5 mL Normal Saline to make total volume 2.0 mL
Time frame: Total analgesic consumption in 24 hours
This will indicate the difference in duration of analgesic effect of bupivacaine + dexmedetomidine group vs group receiving bupivacaine only
Time frame: Total analgesic consumption in 24 hours - The duration of the sensory and motor block and how they gradually wear off over time - Hemodynamic parameters (HR, MAP) - Sedation score (Ramsay Sedation Scale). - Incidence of adverse events bradycardia,hypoten
Shifa International Hospital
Other
"Effect of Adding Low-dose Intrathecal Dexmedetomidine to Hyperbaric Bupivacaine on the Duration and Quality of Spinal Anesthesia in Knee Arthroplasty."
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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