Intrathecal Dexmedetomidine vs Midazolame

Postoperative Pain Clinical Trial

Official title:

Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06315634
• Other study ID #: AP210330102
• Status: Completed
• Phase: Phase 4
• Start date: March 15, 2021
• Est. completion date: March 10, 2022

Study information

• Verified date: March 2024
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective Randomized Controlled Clinical Trial to Compare Intrathecal Dexmedetomidine Versus Midazolame in Orthopedic Cancer Surgeries

Description:

Comparison of intrathecal dexmedetomidine plus Bupivacaine vs intrathecal midazolam plus Bupivacaine on duration of sensory and motor blockade and hemodynamic parameters of patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 10, 2022
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients undergoing lower limb orthopedic cancer surgery.

• ASA I, II, III.

• Age 20 to 70 year

• Healthy volunteers

Exclusion Criteria:

• Age less than 20 and older than 70.

• ASA IV, V.

• patients' refusal.

• patients with coagulopathy.

• patients with severe valvular stenosis

• patients with infection at site of injection

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexmedetomidine
5 micrograms intrathecal dexmedetomidine
• Midazolam
2 milligrams intrathecal midazolam
• Bupivacain
12.5 milligrams 0.5% intrathecal hyperbaric bupivacaine

Locations

Country	Name	City	State
Egypt	National cancer institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of sensory block	Duration of sensory block after spinal anesthesia by the ability of the patient to demonstrate the pinprick sensation	12 hours
Secondary	Incidence of vomiting occurrence	The patient will be reported in case of vomiting occurrence	12 hours
Secondary	Sedation	Ramsay's sedation score1: anxious, agitated and restlessness, 2: oriented and cooperative, 3: responds to command only, 4: brisk response to loud voice and light glabellar tap, 5: sluggish to no response to light glabellar tap or loud auditory stimulus, 6: no response even to pain	12 hours
Secondary	Change in mean arterial blood pressure	Non invasive blood pressure measurement	12 hours
Secondary	Duration of motor block	Ability of patient to regain full motor power	12 hours
Secondary	Change in heart rate	Heart rate will be compared between the three groups and will be compared with baseline preoperative values in each group	12 hours