Maternal Hypotension After Spinal Anesthesia Clinical Trial
Official title:
Effect of Height Versus Height and Weight Based Intrathecal Bupivacaine Dose on Maternal Haemodynamics for Elective Caesarean Section in Short Stature Patients: A Randomized Trial
| Verified date | March 2022 |
| Source | B.P. Koirala Institute of Health Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Doses of intrathecal bupivacaine based on patients either height or height and weight has shown to lower the risk of maternal hypotension with similar quality of anesthesia compared to conventional doses. In clinical practice there is a tendency of reducing the dose of bupivacaine as either low fixed dose or using the doses based on either height and weight or height (0.06mg/cm) alone in parturient with short stature. However, there is lack of evidence regarding the appropriate dose required in this group of patients. Therefore, our aim is to compare the height versus height and weight based intrathecal bupivacaine dose for elective caesarean on maternal haemodynamics in short stature patients.
| Status | Completed |
| Enrollment | 112 |
| Est. completion date | September 1, 2021 |
| Est. primary completion date | September 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility | Inclusion Criteria: - Women with full-term gestation undergoing planned Caesarean section under spinal anesthesia - Who provide consent . - Height less than 150 cm Exclusion Criteria: - Patients with height <140 cm, - Hypertensive disorders of pregnancy, - Placental disorders, - Body mass index = 40 kg/m2, - Diabetes mellitus - Cardiovascular - Cerebrovascular - Hormonal disorder - Renal disease - Polyhydramnios - Known case of bad obstetric history - Fetal abnormalities - Baseline systolic blood pressure (SBP) less than 100 mmHg - Contraindication to spinal anaesthesia - Allergy to any drug used in the study and - Those unable to understand and sign the consent form |
| Country | Name | City | State |
|---|---|---|---|
| Nepal | BP Koirala Institute of Health Sciences (BPKIHS) | Dharan Bazar | Koshi |
| Lead Sponsor | Collaborator |
|---|---|
| B.P. Koirala Institute of Health Sciences |
Nepal,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of post-spinal hypotension | Number of patients with post spinal hypotension (defined as systolic blood pressure in mmHg, <10% of the baseline reading or SBP < 100 mm Hg observed from spinal injection until delivery of baby | Up to delivery of baby | |
| Secondary | Incidence of post-delivery hypotension | Number of patients with post delivery hypotension (defined as systolic blood pressure in mmHg, <10% from the baseline reading or systolic blood pressure < 100 mm Hg observed after delivery of the fetus and starting oxytocin infusion until end of surgery | Up to end of surgery | |
| Secondary | Incidence of post-spinal hypotension | Number of patients with post spinal hypotension (defined as systolic blood pressure in mmHg, <20% of the baseline reading or SBP < 100 mm Hg observed from spinal injection until delivery of baby | Up to delivery of baby | |
| Secondary | Incidence of post-delivery hypotension | Number of patients with post delivery hypotension (defined as systolic blood pressure in mmHg, <20% of the baseline reading or systolic blood pressure < 100 mm Hg observed after delivery of the fetus and starting oxytocin infusion until end of surgery | Up to end of surgery | |
| Secondary | Lowest systolic blood pressure | lowest systolic blood pressure (SBP) recorded in mmHg from spinal injection until delivery and then end of surgery. | Up to end of surgery | |
| Secondary | Vasopressor requirement | Hypotension associated without bradycardia will be treated with phenylepinephrine. Hypotension associated with bradycardia (HR 50/min) will be treated with IV ephedrine 6 mg and followed by IV atropine 0.5 mg. | Up to end of surgery | |
| Secondary | Incidence of bradycardia | Number of patients with heart rate < 50 beats/min | Up to end of surgery | |
| Secondary | Incidence of nausea vomiting | Number of patients complaining nausea and vomiting. Patients will be instructed to report intraoperative nausea based on an 11-point Numeric Rating Score (NRS), where 0 describes "no nausea" and 10 describes nausea "as worst as it could be". Score more than 0 will be considered as nausea. Patients reporting NRS score > 3 for nausea or vomiting will be managed with IV ondensetron 4 mg. If nausea and vomiting persisted after 5 min, IV dexamethasone 4 mg will be administered. | Up to end of surgery | |
| Secondary | Incidence of shivering | Number of patients with shivering. Intraoperative shivering will be graded as : 0 no shivering, 1 one or more of the following: piloerection, peripheral vasoconstriction, peripheral cyanosis without other cause, but without visible muscular activity; 2 visible muscular activity confined to one muscle group; 3 visible muscular activity in more than one muscle group; and 4 gross muscular activity involving the whole body. If the shivering score is =3, IV meperidine 20 mg will be administered. | Up to end of surgery | |
| Secondary | Intraoperative analgesia requirement | Number of patient requiring intraoperative supplemental analgesia. Patients will be instructed to report intraoperative pain based on an 11-point Numeric Rating Score (NRS), where 0 describes "no pain" and 10 describes worst pain "as worst as it could be". It will be assessed using NRS scores at the following intervals: skin incision, delivery, uterine exteriorization, peritoneal closure, and skin closure. If patients reported pain or discomfort (if NRS is mild i.e scores between 1-3), then IV fentanyl 20 microgram will be given and second dose will be repeated if needed. If pain still persists then IV ketamine 0.25 mg/kg will be given. | Up to end of surgery | |
| Secondary | Systolic blood pressure | Systolic blood pressure in mmHg measured from baseline until end of surgery | Up to end of surgery | |
| Secondary | Quality of anaesthesia | Assessed using a four-point scale: 1=excellent, 2=good; some feelings but no discomfort, 3=fair; some discomfort but rescue analgesia unnecessary, 4=poor; major discomfort and rescue analgesia required. | At 1 to 2 hours in Post anesthesia care unit | |
| Secondary | quality of operating condition | Surgeons will be asked to grade operating conditions as "very good," "good," or "poor." | Up to end of surgery | |
| Secondary | Intraoperative sedation | Assessed at 5 min interval after IT injection using a 5-point ordinal scale, where 0 = Awake and alert; 1 = resting with eyes closed; 2 = drowsy and responsive to verbal stimuli; 3 = drowsy and responsive to physical stimuli and 4 = unarousable. | Up to end of surgery | |
| Secondary | Maternal satisfaction with intraoperative anesthesia for cesarean delivery | It will be recorded before discharge from PACU using a NRS with "very dissatisfied" at 0 cm and "very satisfied" at 10 cm. | up to 1-2 hours stay Post anesthesia care unit | |
| Secondary | Incidence of pruritus | Number of patients with pruritus. Intraoperative pruritus will be assessed using NRS scale (0 - 10 scale, with 0, no pruritus, and 10, worst pruritus imaginable). NRS score > 3 will be treated with IV chlorpheniramine 10 mg. | Up to end of surgery | |
| Secondary | Duration of pain free period | Duration of analgesia in hours (time elapsed between intrathecal injection and the first perception of pain) will be noted | up to 24 h after surgery | |
| Secondary | Incidence of dizziness | Number of patients complaining dizziness | up to end of surgery | |
| Secondary | Time to sensory block reached to 6th thoracic dermatome | After spinal anesthesia the time required for sensory block to reach 6th thoracic dermatome | Up to 10 min from injection of spinal anesthesia | |
| Secondary | Maximum level of sensory block reached | level of maximum thoracic/cervical dermatome reached after spinal anesthesia | Up to end of surgery | |
| Secondary | Time to sensory block regressed to 10th thoracic dermatome | After spinal anesthesia the time required for sensory block to regress to 10th thoracic dematome | Up to 24 hour after surgery | |
| Secondary | Time to complete motor blockade | Time to Bromage scale 3. Motor block will be assessed using the Bromage scale (0-3): 0, able to straight leg raise (SLR) and flex both feet and knees; 1, unable to SLR, able to flex knees and feet; 2, unable to SLR or flex knees, able to flex feet; and 3, unable to move legs or feet. | Upto 15 min after spinal anesthesia | |
| Secondary | Time to motor blockage regression | Time to Bromage scale regression to 0. Motor block will be assessed using the Bromage scale (0-3): 0, able to straight leg raise (SLR) and flex both feet and knees; 1, unable to SLR, able to flex knees and feet; 2, unable to SLR or flex knees, able to flex feet; and 3, unable to move legs or feet. | Up to 24 hour after surgery | |
| Secondary | Apgar score | Neonatal Apgar scores after delivery assessed by attending pediatrician. It is determined by evaluating the newborn baby on five criteria(Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low requiring immediate resuscitation. | 5 and 10 minutes after delivery |