Comparison of analgesic efficacy of ketamine versus magnesium sulphate as adjuvant to intrathecal bupivacaine in parturients undergoing elective caesarean section – a randomised interventional study at SMS Medical College & attached group of hospital, Jaipur
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. To assess & compare between two groups the mean duration of analgesia.
研究概览
简要总结
In this study, we plan to study and draw a comparison of additives like ketamine and magnesium sulphate to hyperbaric bupivacaine to determine their effectiveness in improving the overall quality of anaesthesia in parturients posted for elective caesarean sections.
For this a total of Sixty patients (n=60) undergoing elective caesarean section who satisfy the inclusion criteria will be randomly divided into two groups of 30 each(A and B). Group A patients will be receiving intrathecal ketamine (25 mg) as additive to hyperbaric bupivacaine and group B will be receiving magnesium sulphate (75 mg) as additive to hyperbaric bupivacaine.
When patients arrive in the operating room (OR), intravenous cannula (IV cannula) will be inserted and hemodynamic variables will be measured. After this spinal anaesthesia will be administered using ketamine as an additive to bupivacaine in group A and magnesium sulphate in group B. Surgery will be allowed to proceed after the block reaches T6 sensory level (complete sensory block). Quantitative values of time of onset of sensory loss, time of onset of motor loss, time taken for sensory regression, time taken for motor regression, duration of analgesia will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •patients going for elective caesarean section under spinal anaesthesia.Patients who will give informed written consent in vernacular language.Belonging to ASA Classes II status.Height of the parturient 145–170 cm.
排除标准
- •Patients with systemic diseases.Patients with body mass index >38kg/cm2.Patients having history of preeclampsia and eclampsia,fetal distress.
- •Patients having allergy to study drug.Patients having contraindications to spinal anaesthesia.
- •â€¢ Patients consuming tranquilizers, hypnotics, sedatives.
结局指标
主要结局
1. To assess & compare between two groups the mean duration of analgesia.
时间窗: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
2. To determine difference in mean time duration of sensory onset of spinal anaesthesia
时间窗: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
between bupivacaine & ketamine versus bupivacaine and magnesium sulphate in
时间窗: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
parturients undergoing elective caesarean section using pin prick method.
时间窗: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
3. To assess and compare between two groups the mean time duration in motor onset
时间窗: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
using bromage score.
时间窗: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
4. To assess and compare between two groups the mean time duration for sensory
时间窗: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
regression using pin prick sensation.
时间窗: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
5. To assess and compare between two groups the mean time duration for motor regression
时间窗: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
using bromage scale.
时间窗: Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed.
次要结局
- 1. To assess & compare hemodynamic changes between the two groups.(2. Study any adverse effects associated with drugs given.)