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Spinal Tramadol and spinal Magnesium sulfate along with Levobupivacaine in pregnanacy induced hypertensive parturients undergoing cesarean section.

Comparison of intrathecal Tramadol and magnesium sulfate as an adjuvant to Levobupivacaine in mild preeclamptic parturients undergoing cesarean section-a prospective randomized control study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009562
Enrollment
60
Registered
2017-08-31
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

Health Condition 1: null- All those mild preeclamptic parturients who comes under ASA physical status II and III

Interventions

Intervention1: Intrathecal Tramadol: Mild preeclamptic parturient given Levobupivacaine 1.5 ml with Tramadol 0.5ml (25mg) to be observed for 24 hours postoperatively Control Intervention1: Intrathecal

Sponsors

Medical College and SSGHospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age group 18-40 years 2. Mild Preeclamptic parturient with controlled hypertension. 3. Singleton pregnancy 4. Elective LSCS 5. Normal bleeding profile (BT, CT, PT) 6. More than 36 weeks of pregnancy 7. ASA II and ASA III

Exclusion criteria

Exclusion criteria: 1. signs of HELLP syndrome 2. fetal distress and Cord prolapse 3. Patients with contraindications to spinal anaesthesia 4. Patients with a significant history of drug or alcohol abuse 5. Morbid obesity(BMI >35 kg/m2) 6. Previous LSCS 7. Diabetic, neurological or musculoskeletal diseases 8. Unable to understand VAS. 9. Thrombocytopenia (platelet count 10. parturients receiving magnesium therapy 11. Placental abnormalities like placenta previa and abruptio placenta

Design outcomes

Primary

MeasureTime frame
1. Sensory Blockade 2. Motor Blockade. 3. Postoperative analgesia Timepoint: Sensory Block and motor block was assessed at 30 sec then every minute till 5 minutes and then at 7,10 minutes and for post operative analgesia VAS was assessed postoperatively at the interval of 1 hour up to 4 hours then at interval of 2 hours for 24 hours. Rescue Analgesia Inj. Diclofenac Sodium 75 mg IM was given when VAS â?¥ 4 or on patient demand as a rescue analgesia.—

Secondary

MeasureTime frame
1. Sedation score 2. Hemodynamic parameters like Pulse rate, Systolic, Diastolic and Mean arterial blood pressure, Respiratory rate and Oxygen saturation. . Complications, if any.Timepoint: Sedation score was assessed at 5 min and 35 min after following spinal anaesthesia. Hemodynamic paraneters were assessed at 1,3,5,7,10,15,20,30,40,50 minutes intraoperatively ans for 24 hours post operatively.—

Countries

India

Contacts

Public ContactDrAditi A Dhimar

Medical College and S.S.G.Hospital, VadodaraÂ

dhimaraditi@yahoo.in9825334605

Outcome results

None listed

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