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A study to compare the effect of low dose versus conventional dose intrathecal fentanyl with hyperbaric bupivacaine on the block characteristics in parturient undergoing caesarean section under spinal anaesthesia

Effect of low dose versus conventional dose intrathecal fentanyl with hyperbaric bupivacaine on the block characteristics in parturient undergoing caesarean section under spinal anaesthesia : a randomised controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035932
Enrollment
60
Registered
2021-08-25
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: O82- Encounter for cesarean delivery without indication

Interventions

Intervention1: jhfhfghjjhhjhvhv: ggcgcccgcg Intervention2: Intrathecal (hyperbaric bupivacaine with fentanyl citrate): 2ml 0.5% hyperbaric bupivacaine with 0.5ml (12.5 mcg) fentanyl citrate Control In

Sponsors

Lairikyengbam Sheityajit Roy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (ASA) physical status I or II undergoing lower segment caesarean section under spinal anaesthesia

Exclusion criteria

Exclusion criteria: 1. History of allergy to study drugs 2. Bleeding disorder-platelet count time >14sec,International normalised ratio(INR)- >1.5 3. Local site infection 4. Cardiac, respiratory diseases and kidney disorder, neurological deficit 5. Spinal deformity

Design outcomes

Primary

MeasureTime frame
Duration of analgesia [Time (minutes) to demand of first rescue analgesic assessed by visual analogue scale]Timepoint: From time of intrathecal injection (baseline) to the time when patient first demands rescue analgesia (minutes)—

Secondary

MeasureTime frame
1. Hemodynamic profile- pulse rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), Oxygen saturation (SpO2) 2. Time of sensory block at onset T 10(secs) 3. Maximum sensory level achieved 4. Time to achieve maximum sensory level(secs) 5. Time to complete motor blockade(secs) 6. Time to two segment regression(mins) 7. Time to sensory regression to S2(mins) 8. Side effects Timepoint: 1. Hemodynamic profiles will be assessed at baseline, every 2 minutes till 10 minutes and then every 5 mins till the end of surgery. 2. The various time intervals will be assessed just after the intrathecal injection and then every 2 mins along the mid -clavicular line, bilaterally till the desired effect/ regression were achieved(sec/mins). The maximum sensory level achieved was also assessed in the mid -clavicular line bilaterally.—

Countries

India

Contacts

Public ContactProf Dr N Ratan Singh

Regional Institute of Medical Sciences, Imphal

drnratansingh@gmail.com9436027270

Outcome results

None listed

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