To study and compare the analgesic effect of Dexmedetomidine with Levobupivacaine, Ropivacaine and Bupivacaine under spinal anesthesia.

To study the efficacy of Dexmedetomidine as an adjuvant to hyperbaric preparations of 0.5% Levobupivacaine, 0.75% Ropivacaine & 0.5% Bupivacaine in the patients undergoing surgeries under subarachnoid block

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/054099

Enrollment

Registered

2023-06-19

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: subarachnoid block: 3.5 ml hyperbaric bupivacaine 3.5 ml hyperbaric levobupivacaine 3.5 ml hyperbaric ropivacaine 12.5mcg of dexmedetomidine in each group for duration approx 2 hrs

Eligibility

Inclusion criteria

Inclusion criteria: Consent from patients and ASA grading I-II posted for lower abdominal and lower limb surgical procedures planned under subarachnoid block.

Exclusion criteria

Exclusion criteria: Non consenting as well pregnant patients, any spinal deformities, infection at the site,uncontrolled co-existing systemic and metabolic diseases, history of alcohol abuse, known sensivity to any LAAs and dexmedetomidine shall be excluded from the study , patients on beta blockers and sinus bradycardia

Design outcomes

Secondary

Measure	Time frame
To find out side effects & complications, if any.Timepoint: VAS monitoring continued every 6 hours for next 24 hours. V0 :- VAS at the time of giving spinal (T0) V1:- peak of sensory block (T3) V2:- 2 segment regression (T5) V3:- injection of rescue analgesia (T6) V4:- at the time of shifting to the ward (T7) V5,V6,V7 & V8 will be the measurement of VAS for next 24 hours. After 24 hours, patient will be shifted to systemic analgesics & released from the study.	—

Measure

Time frame

To find out side effects & complications, if any.Timepoint: VAS monitoring continued every 6 hours for next 24 hours. V0 :- VAS at the time of giving spinal (T0) V1:- peak of sensory block (T3) V2:- 2 segment regression (T5) V3:- injection of rescue analgesia (T6) V4:- at the time of shifting to the ward (T7) V5,V6,V7 & V8 will be the measurement of VAS for next 24 hours. After 24 hours, patient will be shifted to systemic analgesics & released from the study.

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Primary

Measure	Time frame
Onset, peak & level of Sensory block ( in seconds) Onset, peak & level of Motor block ( in seconds) Total duration of Analgesia (in minutes) Time for rescue Analgesia (in minutes) Total doses & amount (in mg ) of rescue analgesia Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2)Timepoint: Onset, peak & level of Sensory block ( in seconds) Onset, peak & level of Motor block ( in seconds) Total duration of Analgesia (in minutes) Time for rescue Analgesia (in minutes) Total doses & amount (in mg ) of rescue analgesia Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2) every 3 minutes till block achieved then every 10 minutes	—

Measure

Time frame

Onset, peak & level of Sensory block ( in seconds) Onset, peak & level of Motor block ( in seconds) Total duration of Analgesia (in minutes) Time for rescue Analgesia (in minutes) Total doses & amount (in mg ) of rescue analgesia Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2)Timepoint: Onset, peak & level of Sensory block ( in seconds) Onset, peak & level of Motor block ( in seconds) Total duration of Analgesia (in minutes) Time for rescue Analgesia (in minutes) Total doses & amount (in mg ) of rescue analgesia Haemodynamic parameters ( HR, PR,SBP,DBP, MAP, RR, SPO2) every 3 minutes till block achieved then every 10 minutes

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Countries

India

Contacts

Public ContactDr Ritika

N C Medical College and Hospital Israna Panipat

drmmprao1@gmail.com6280581885

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026