AzTrials
AzTrials

Intrathecal DexmedetomidinePhase 1/2NCT07807020

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).

A Phase 1/2 study testing Intrathecal Dexmedetomidine in people with Intrathecal Dexmedetomidine, run by Shifa International Hospital at 1 site in Pakistan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Intrathecal Dexmedetomidine
What is being tested?
Intrathecal Dexmedetomidine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 sitePakistan
Study dates
4 May 2026to 4 May 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Classified as ASA physical status II-III
  • Scheduled for elective lower limb joint replacement surgeries ( total knee replacement [TKR]) - Written informed consent

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pakistan1 site
  • Shifa International Hospital Islamabad

    Islamabad, Federal, 44000

Other trials in Pakistan

About this study

Official title: "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.

Read the 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).

Being tested
Intrathecal Dexmedetomidine, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intrathecal DexmedetomidineDrug

    Also called precidex

    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

  • PlaceboOther

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

Study groups in NCT07807020
Study groupRoleWhat they receive
Group A: Interventional group recieving intrathecal dexmedetomidine and bupivicaine + salineExperimental1.5 mL of 0.75% hyperbaric bupivacaine + 4 µg dexmedetomidine + Normal Saline to make total
Receives: Drug: Intrathecal Dexmedetomidine
Group B (Control): 1.5 mL of 0.75% hyperbaric bupivacaine + 0.5 mL Normal Saline to make total volumPlacebo comparatorno dexmedetomidine will be given in this group instead normal saline with hyperbaric bupivicaine will be used intrathecally to make total volume of 2ml.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from spinal injection to first postoperative analgesic request

    This will indicate the difference in duration of analgesic effect of bupivacaine + dexmedetomidine group vs group receiving bupivacaine only

    Measured: Total analgesic consumption in 24 hours

Secondary outcomes (1)
  1. Secondary Outcome Measure

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2026
  2. Study start4 May 2026
  3. Primary completion4 May 2027 (estimated)
  4. Study completion4 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07807020
Sponsor's protocol ID
ShifaH
Status last verified
Aug 2026
First submitted
25 Aug 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: It can be shared while keeping the individual participant identity anonymous.

Publications

  • Anaesth Pain Intensive Care. Cochrane Central Register of Controlled Trials and sourced from Embase. 2019;23(2):198-203

  • Ioannidis R, Zapantis-Gakis C, Zarogianni T, Manouskou N, Sarridou D. Dexmedetomidine in Spinal Anesthesia for Orthopedic Surgery: Extending Analgesia Beyond the Operating Room. Cureus. 2025 Oct 22;17(10):e95136. doi: 10.7759/cureus.95136. eCollection 2025 Oct.

    PubMed 41281055
  • . Eur J Mol Clin Med. Cochrane Central Register of Controlled Trials and sourced from Embase2022;9(7):2179-2186.

  • Ann Pak Inst Med Sci. 2025;21(2):474-8. doi:10.48036/apims.v21i2.1145

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Intrathecal Dexmedetomidine in people with Intrathecal Dexmedetomidine, run by Shifa International Hospital at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from spinal injection to first postoperative analgesic request (time frame: Total analgesic consumption in 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07807020, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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