NCT07807020

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
7mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
May 2026May 2027

Study Start

First participant enrolled

May 4, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 8, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2027

Last Updated

September 8, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 25, 2026

Last Update Submit

September 2, 2026

Conditions

Intrathecal Dexmedetomidine

Outcome Measures

Primary Outcomes (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

    Total analgesic consumption in 24 hours

Secondary Outcomes (1)

  • Secondary Outcome Measure

    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

Study Arms (2)

Group A: Interventional group recieving intrathecal dexmedetomidine and bupivicaine + saline

EXPERIMENTAL

1.5 mL of 0.75% hyperbaric bupivacaine + 4 µg dexmedetomidine + Normal Saline to make total

Drug: Intrathecal Dexmedetomidine

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

PLACEBO COMPARATOR

no dexmedetomidine will be given in this group instead normal saline with hyperbaric bupivicaine will be used intrathecally to make total volume of 2ml.

Other: Placebo

Interventions

Intrathecal DexmedetomidineDRUG

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

Also known as: precidex
Group A: Interventional group recieving intrathecal dexmedetomidine and bupivicaine + saline
PlaceboOTHER

Group B (Control): 1.5 mL of 0.75% hyperbaric bupivacaine + 0.5 mL 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 volum

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shifa International Hospital Islamabad

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (4)

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

    RESULT

  • 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.

    PMID: 41281055RESULT

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

    RESULT

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

    RESULT

Related Links

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident anestheia

Study Record Dates

First Submitted

August 25, 2026

First Posted

September 8, 2026

Study Start

May 4, 2026

Primary Completion (Estimated)

May 4, 2027

Study Completion (Estimated)

May 4, 2027

Last Updated

September 8, 2026

Record last verified: 2026-08

Locations

PA(1)