Study the effects of one drug(dexmedetomidine) via two different routes i.e., through the vein or into the spinal fluid along with a common drug(bupivacaine) injected into the spinal fluid to eliminate the feeling of pain in patients undergoing lower limb and lower abdomen surgery.

Effect of intrathecaldexmedetomidine versus intravenous dexmedetomidine on subarachnoid anaesthesia with hyperbaric bupivacaine

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/08/015301

Enrollment

Registered

2018-08-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: dexmedetomidine: Group B (Group Bupivacaine)Patients in this group (constituting the control group) received 20 mL of 0.9% salineintravenously over 10 minutes

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients undergoing elective infraumbilical or lower limb surgery under spinal anaesthesia 2.Belonging to American Society of Anaesthesiologists Physical Status 1 or 2

Exclusion criteria

Exclusion criteria: 1.coagulopathy 2.hypovolaemia 3.BMI >35kg/m2 4.spinal abnormality 5.chronic use of sedatives or antidepressants 6.history of regular alcohol consumption local infection over lumbar spine

Design outcomes

Primary

Measure	Time frame
1.Onset of sensory and motor blockade 2.Time to achieve maximum sensory level 3.Time for 2-segment regression 4.sensory and motor recoveryTimepoint: 1.Sensory and motor blockade was checked every 2 minutes until the desired level was obtained. Every 5 minutes thereafter till the end of 1 hour, and every 15 minutes thereafter till end of procedure. 3.Sedation score was recorded every 15 minutes throughout the first 3 hours. 4.Blood pressure and heart rate was recorded every 5 minutes for the first hour and every 15 minutes thereafter till complete sensory and motor recovery	—

Measure

Time frame

1.Onset of sensory and motor blockade 2.Time to achieve maximum sensory level 3.Time for 2-segment regression 4.sensory and motor recoveryTimepoint: 1.Sensory and motor blockade was checked every 2 minutes until the desired level was obtained. Every 5 minutes thereafter till the end of 1 hour, and every 15 minutes thereafter till end of procedure. 3.Sedation score was recorded every 15 minutes throughout the first 3 hours. 4.Blood pressure and heart rate was recorded every 5 minutes for the first hour and every 15 minutes thereafter till complete sensory and motor recovery

—

Secondary

Measure	Time frame
1. Sedation score( Ramsay sedation score) 2. Hemodynamic parameters(Blood Pressure 25% decrease was treated, heart rate 50bpm was treated as per the discretion of concerned anaesthesologist, Respiratory rare 8/min or spO2 95% was taken as significant. Timepoint: 2	—

Countries

India

Contacts

Public Contactdrnita varghese

manipal university

nitavarghese@gmail.com9901729764

Outcome results