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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Incidence of post-spinal hypotension
研究概览
简要总结
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.
详细描述
Spinal induced hypotension in women undergoing caesarean section (CS) is the most common unwanted effect. The dose of intrathecal local anesthetic is the main determining factor that balances between successful block and an incidence of maternal hypotension. Although lowering the doses of intrathecal bupivacaine provides better maternal hemodynamic stability it compromises the quality of anesthesia. Moreover, there is no consensus regarding the cut-off at which the dose can be defined as low. Doses 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.
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.
Doses of intrathecal bupivacaine for elective caesarean section based on Harten chart is available from the following reference- Harten JM, Boyne I, Hannah P, Varveris D, Brown A. Effects of a height and weight adjusted dose of local anaesthetic for spinal anaesthesia for elective Caesarean section. Anaesthesia 2005; 60: 348-53.
Consent for the participation in the study will be obtained during pre-anaesthetic assessment visits in the evening before surgery. The investigator will also educate the patients regarding the use of numeric rating scale scores. Preoperative anxiety will be recorded in numerical rating scale scores where 0 is no anxiety and 10 is maximum anxiety patient reported. The enrolled subjects will be randomly assigned to 2 equal groups (allocation ratio, 1:1) according to the codes generated from the website (www.sealedenvleop.com) using the variable block size of 4, 6 and 8. The group allocation will be concealed in sequentially numbered, sealed opaque envelopes that will be opened by the anaesthesia assistant not involved in the study only after the patient arrives in the operating room. The patient will be fasted for at least eight hours and will receive antibiotics, ranitidine 50 mg and metoclopramide 10 mg intravenously via 18-gauge cannula before transfer to the operation room. In the operating table patient will be laid supine with a wedge under right buttock and standard monitors (electrocardiography, pulse oximetry, and noninvasive BP) will be applied. Thereafter, successive three readings of heart rate (HR) and systolic blood pressure (SBP) will be taken at 2 minutes interval with difference not exceeding 10%. The average of these recordings will be documented by the investigators as baseline parameters. To maintain blinding, the investigator will leave the operating room and will return immediately once the spinal injection is initiated. Subarachnoid block will be performed by the attending anesthesiologist not involved in the study in the sitting position at the L3-L4 or L4-L5 vertebral interspace using a 25-gauge spinal needle via midline approach. The study solution will be administered according to the group allocated. In Group A the dose of heavy bupivacaine will be based on height and weight and in group B the dose will be based on patient's height (0.06 mg/cm). 10 microgram fentanyl will be added to bupivacaine in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with full-term gestation undergoing planned Caesarean section under spinal anesthesia
- •Who provide consent .
- •Height less than 150 cm
排除标准
- •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
研究组 & 干预措施
Height and weight based group
Patients in "Height and weight based group" will receive intrathecal hyperbaric bupivacaine based on patients height and weight according to Harten chart with 10 μg of fentanyl (0.1 ml)
干预措施: Hyperbaric bupivacaine spinal (Drug)
Height based group
Patients in "Height based group" will receive intrathecal hyperbaric bupivacaine based on patients height i.e. (0.06mg/cm) with 10 μg of fentanyl (0.1 ml)
干预措施: Hyperbaric bupivacaine spinal (Drug)
结局指标
主要结局
Incidence of post-spinal hypotension
时间窗: Up to delivery of baby
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
次要结局
- Incidence of pruritus(Up to end of surgery)
- Time to sensory block regressed to 10th thoracic dermatome(Up to 24 hour after surgery)
- Incidence of post-spinal hypotension(Up to delivery of baby)
- Systolic blood pressure(Up to end of surgery)
- Quality of anaesthesia(At 1 to 2 hours in Post anesthesia care unit)
- quality of operating condition(Up to end of surgery)
- Intraoperative sedation(Up to end of surgery)
- Incidence of dizziness(up to end of surgery)
- Time to motor blockage regression(Up to 24 hour after surgery)
- Lowest systolic blood pressure(Up to end of surgery)
- Incidence of bradycardia(Up to end of surgery)
- Incidence of nausea vomiting(Up to end of surgery)
- Intraoperative analgesia requirement(Up to end of surgery)
- Duration of pain free period(up to 24 h after surgery)
- Time to sensory block reached to 6th thoracic dermatome(Up to 10 min from injection of spinal anesthesia)
- Time to complete motor blockade(Upto 15 min after spinal anesthesia)
- Incidence of post-delivery hypotension(Up to end of surgery)
- Vasopressor requirement(Up to end of surgery)
- Incidence of shivering(Up to end of surgery)
- Maternal satisfaction with intraoperative anesthesia for cesarean delivery(up to 1-2 hours stay Post anesthesia care unit)
- Maximum level of sensory block reached(Up to end of surgery)
- Apgar score(5 and 10 minutes after delivery)
研究者
Dr Asish Subedi
Principal Investigator
B.P. Koirala Institute of Health Sciences
