Cesarean Section Complications
Conditions
Keywords
Elective low segment caesarean section, Intrathecal, bupivacaine-fentanyl, bupivacaine-dexmedetomidine, sensory block, complications, hemodynamics
Brief summary
the primary objective of the study is to compare the onset and recovery times of sensory and motor blockade of the two study drugs intrathecally with low dose bupivacaine The secondary objectives of the study are to observe hemodynamics, side effects profile, and duration of postoperative analgesia
Detailed description
The current study is undertaken to compare the effect of two drugs intrathecally.edexmedetomidine and fentanyl with a low dose of bupivacaine and assess the adequacy of the block, side effect profile and postoperative analgesia. The two drugs have been studied separately but the comparative data is scarcely available both at national and international level. A particular agent is a dexmedetomidine that has been introduced in the investiagator's setup for the first time so this research will be of great importance in adding its multiple uses other than being used as ICU and procedural sedation agent.
Interventions
Group A: hyperbaric Bupivacaine 10mg with fentanyl 10micrograms,
DRUGBupivacaine, dexmedetomidine
Group B: hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms
Sponsors
Dow University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
Patients were randomly allocated into two groups and will be blinded to the study drugs. The drugs will be chosen by seal envelope method by principal investigator and co-investigator. The drugs will be filled in the syringes and the syringes handed over to on floor consultant anesthetist who are blinded to the study.
Intervention model description
Randomize controlled trial (RCT)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Term pregnancy Singleton ASA I and II, BMI \<35, elective C/section
Exclusion criteria
patient refusal, contraindications to spinal anaesthesia. ASA III and IV, PIH Pre Eclampsia, allergic to Local Anesthetic, fetal anomalies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time till T10 dermatome achieved (Sec) | Post operative initial hour | Spinal block characteristics |
| Post-operative pain score | 1 hour | VAS score indicate 0 no pain 10 severe pain. Pain score was noted down |
| Time of complete motor recovery (Min) | Post operative initial hour | Spinal block characteristics |
| Regression time to T10 dermatome (Min) | Post operative initial hour | Spinal block characteristics |
| Time of maximum bromage achieved (Sec) | Post operative initial hour | Spinal block characteristics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory distress | 24 hours Post operative | Difficulty in breathing |
| Nausea | 24 hours Post operative | Sensation to throw out stomach contents |
| Vomiting | 24 hours Post operative | Act of throwing out stomach contents through mouth |
| Pruritus | 24 hours Post operative | Unpleasing sensation on the skin that provokes to scratch |
| Shivering | 24 hours Post operative | The act of shaking slightly and uncomfortably due to felling of cold temperature |
| Bradycardia | 24 hours Post operative | Heat rate less than \<60 bpm |
| Hypotension | 24 hours Post operative | Decrease in BP greater than 20% of baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| SBP | at 10 minute | Hemodynamics |
| respiratory rate | Baseline | Hemodynamics |
| oxygen saturation | Baseline | Hemodynamics |
| Systolic Blood Pressure | Baseline | Hemodynamics |
| Heart Rate | Baseline | Hemodynamics |
| Diastolic Blood Pressure | Baseline | Hemodynamics |
Countries
Pakistan
Outcome results
None listed