Comparison of two different doses of dexmedetomidine drug as adjuvant to ropivacaine drug in epidural labor analgesia in pregnant women.

To compare the efficacy and safety of two different doses of dexmedetomidine 0.2 mcg per ml and 0.5 mcg per ml as adjuvant to ropivacaine 0.2 percent for epidural labor analgesia. A prospective randomized control trial - NILL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075255

Enrollment

100

Registered

2024-10-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: O759- Complication of labor and delivery, unspecified

Interventions

Intervention1: Dexmedetomedine 0.2 mcg/ml: EFFICACY AND SAFETY OF 0.2 MCG/ML DOSE OF DEXMEDETOMIDINE AS ADJUVANT TO ROPIVACAINE FOR EPIDURAL LABOR ANALGESIA. TOTAL DURATION OF INTERVENTION : 4-8 HOURS

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 to 30 years 2. Term primi gravida, cephalic singleton pregnancy 3. Uterine contractions at least once in 5 minutes with cervical dilatation 3 to 4 cm

Exclusion criteria

Exclusion criteria: 1. Patient having history of allergy to Local anesthetic agent 2. Patient having preterm labor, pre-eclampsia, eclampsia, thyroid disorder, cardiomyopathies, multiple pregnancy, previous LSCS, Abnormal lie, antepartum hemorrahge, morbid obesity, severe anemia, hemodynamic instability 3. Any psychiatric or neurological disorder or altered mental status

Design outcomes

Primary

Measure	Time frame
• To compare the quality of pain relief using VAS (Visual Analogue Scale) score. Timepoint: Before bolus At 10 min of bolus At 20 min of bolus At 30 min of bolus At 1 hour of bolus At 1.5 hour of bolus At 2 hour of bolus At 2.5 hour of bolus At 3 hour of bolus At 3.5 hour of bolus At 4 hour of bolus Every half hourly till expulsion of placenta	—

Secondary

Measure	Time frame
1. To compare hemodynamic parameters changes(pulse, blood pressure, spo2) during labor 2. To compare duration of progression of 1 st , 2 nd and 3 rd stage of labor. 3. To compare total dose of ropivacaine(0.2%) with dexmedetomidine required for labor analgesia 4. To compare fetal heart sound during labor. 5. To compare the percentage(%) of instrumental delivery(including Cesarean section) 6. To compare the degree of motor blockade, if present, using modified Bromage scale (Grade 1-4) 7. To compare sedation in mother using Ramsay Sedation Scale(RSS) 8. To compare the neonatal outcome in the form of APGAR score after delivery of baby at 1 minute and 5 minute 9. To compare maternal satisfaction using likert scale 10. To compare obstetrician satisfaction likert scaleTimepoint: Before bolus At 10 min of bolus At 20 min of bolus At 30 min of bolus At 1 hour of bolus At 1.5 hour of bolus At 2 hour of bolus At 2.5 hour of bolus At 3 hour of bolus At 3.5 hour of bolus At 4 hour of bolus Every half hourly till expulsion of placenta	—

Measure

Time frame

1. To compare hemodynamic parameters changes(pulse, blood pressure, spo2) during labor 2. To compare duration of progression of 1 st , 2 nd and 3 rd stage of labor. 3. To compare total dose of ropivacaine(0.2%) with dexmedetomidine required for labor analgesia 4. To compare fetal heart sound during labor. 5. To compare the percentage(%) of instrumental delivery(including Cesarean section) 6. To compare the degree of motor blockade, if present, using modified Bromage scale (Grade 1-4) 7. To compare sedation in mother using Ramsay Sedation Scale(RSS) 8. To compare the neonatal outcome in the form of APGAR score after delivery of baby at 1 minute and 5 minute 9. To compare maternal satisfaction using likert scale 10. To compare obstetrician satisfaction likert scaleTimepoint: Before bolus At 10 min of bolus At 20 min of bolus At 30 min of bolus At 1 hour of bolus At 1.5 hour of bolus At 2 hour of bolus At 2.5 hour of bolus At 3 hour of bolus At 3.5 hour of bolus At 4 hour of bolus Every half hourly till expulsion of placenta

—

Countries

India

Contacts

Public ContactDr Komal Shah

Government medical College

shah.komal212@gmail.com9427215252

Outcome results

None listed

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