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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).

"Effect of Adding Low-dose Intrathecal Dexmedetomidine to Hyperbaric Bupivacaine on the Duration and Quality of Spinal Anesthesia in Knee Arthroplasty."

Status
Enrolling by invitation
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07807020
Enrollment
60
Registered
2026-09-08
Start date
2026-05-04
Completion date
2027-05-04
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrathecal Dexmedetomidine

Brief summary

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.

Detailed description

"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 * To compare the duration of sensory block between two groups. * To compare the duration of motor block between two groups. * To evaluate intraoperative and postoperative hemodynamic stability ( Heart rate and Mean Arterial Pressures). * To determine the incidence of adverse effects (bradycardia, hypotension, nausea, sedation) in both groups. Methodology Study design Quasi-experimental, non-randomized controlled design Study setting * Department of anesthesia, Shifa International Hospital Ltd. Study duration * 12 Months Sample Size and Study Groups Total 60 patients (30 per group) based on power analysis. 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 * Patients aged between 18 and 60 years * Classified as ASA physical status II-III * Scheduled for elective lower limb joint replacement surgeries ( total knee replacement \[TKR\]) * Written informed consent Exclusion Criteria * Allergy to study drugs * Contraindications to spinal anesthesia * History of cardiac conduction abnormalities or severe bradycardia * Neurological or psychiatric illness * Pregnancy or lactation 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: \- Time from spinal injection to first postoperative analgesic request. Secondary Outcomes: * 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, hypotension, nausea, shivering) Timeline Total duration: 12 months ( 8 months data collection, 2 months analysis, 2 months reporting).

Interventions

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

OTHERPlacebo

Group B (Control): 1.5 mL of 0.75% hyperbaric bupivacaine + 0.5 mL Normal Saline to make total volume 2.0 mL

Sponsors

Shifa International Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

• Patients aged between 18 and 60 years * Classified as ASA physical status II-III * Scheduled for elective lower limb joint replacement surgeries ( total knee replacement \[TKR\]) - Written informed consent

Exclusion criteria

Allergy to study drugs * Contraindications to spinal anesthesia * History of cardiac conduction abnormalities or severe bradycardia * Neurological or psychiatric illness * Pregnancy or lactation

Design outcomes

Primary

MeasureTime frameDescription
Time from spinal injection to first postoperative analgesic requestTotal analgesic consumption in 24 hoursThis will indicate the difference in duration of analgesic effect of bupivacaine + dexmedetomidine group vs group receiving bupivacaine only

Secondary

MeasureTime frame
Secondary Outcome MeasureTotal 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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026