Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering Following Subarachnoid Block
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 130
- 主要终点
- Presence of Post anaesthetic shivering measured by the Crossley and Mahajan Scale
研究概览
简要总结
Post Anaesthetic Shivering is a common complication of Subarachnoid block. It is graded based on it's severity and has been known to cause various problems like patient's discomfort, hypoxia, change in hemodynamic variables of the patient and poor wound healing. This problem has been managed via pharmacologic and non-pharmacologic means. Non-pharmacologic modalities involve options aimed at warming the patient. Pharmacologically, opioids are used more commonly to prevent and treat this condition. This then introduces the side effect of nausea/vomiting and sedation which may reduce overall patient's satisfaction on the perception of the Subarachnoid block. It is for this reason that Nefopam - a centrally acting non-opioid, non-steroidal anti-inflammatory drug (NSAID) analgesic, relatively new drug in the Nigerian market with significant anti-shivering effect is compared with a well established opioid like Tramadol. Having similar cost profile, the option of replacing Tramadol with Nefopam especially in conditions where the patient is more hemodynamically unstable is considered in this project.
详细描述
STUDY LOCATION This study would be carried out in Gbagada General Hospital and other General hospitals in Lagos state.
They are all secondary health care facilities with 800 bed spaces in Gbagada and about 3000 in the other centres. Gbagada is a suburban area centrally located in Lagos state and the General hospital was established in 1983.
STUDY DESIGN The study would be a prospective, double-blinded, randomised control study in which both the investigator and the patient would be blinded to the study drugs.
Patients would be randomised into 2 groups. In one group, patients would be given 1mg/kg of tramadol diluted with water for injection to a volume of 10mls. In the second group patients would receive 0.15mg/kg of nefopam diluted with water for injection up to a volume of 10mls.
STUDY POPULATION Patients aged 18 to 45 years with American Society of Anesthesiologists (ASA) physical status II or III scheduled for Caesarean Sessions (CS) amenable to Subarachnoid block who have given written informed consent will be recruited into this study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female Patients
- •Aged 18 to 45 years.
- •American Society of Anesthesiologists (ASA) physical status II or III
- •Caesarean Sessions (CS) amenable to Subarachnoid block
- •Written informed consent
排除标准
- •Patients who refuse to sign consent
- •Patients with thyroid diseases
- •Patients with cardiopulmonary diseases
- •Patients with neuromuscular diseases or psychological disorders
- •Patients prior on narcotics, sedatives, misoprostol or any medication likely to alter thermoregulation
- •Patients with recent history of febrile illness
- •Patients with history of malignant hyperthermia
研究组 & 干预措施
Nefopam
Premedication of IV (Intravenous)10mg Metoclopramide and 50mg Ranitidine would be given morning of surgery to all patients.
0.15mg/kg of Acupan(Nefopam) would be administered IV after the initiation of the subarachnoid block (Time 0) and presence and severity of shivering (the primary outcome) would be looked out for.
IV Ephedrine in 3mg alliquots would be given if hypotension occurs; IV oxytocin 30-50mg would be given after delivery of the baby to all patients and IV Pethidine 25mg would be given to abate any residual shivering if a repeat dose of Acupan is not satisfactory.
干预措施: Nefopam (Drug)
Nefopam
Premedication of IV (Intravenous)10mg Metoclopramide and 50mg Ranitidine would be given morning of surgery to all patients.
0.15mg/kg of Acupan(Nefopam) would be administered IV after the initiation of the subarachnoid block (Time 0) and presence and severity of shivering (the primary outcome) would be looked out for.
IV Ephedrine in 3mg alliquots would be given if hypotension occurs; IV oxytocin 30-50mg would be given after delivery of the baby to all patients and IV Pethidine 25mg would be given to abate any residual shivering if a repeat dose of Acupan is not satisfactory.
干预措施: Metoclopramide (Drug)
Nefopam
Premedication of IV (Intravenous)10mg Metoclopramide and 50mg Ranitidine would be given morning of surgery to all patients.
0.15mg/kg of Acupan(Nefopam) would be administered IV after the initiation of the subarachnoid block (Time 0) and presence and severity of shivering (the primary outcome) would be looked out for.
IV Ephedrine in 3mg alliquots would be given if hypotension occurs; IV oxytocin 30-50mg would be given after delivery of the baby to all patients and IV Pethidine 25mg would be given to abate any residual shivering if a repeat dose of Acupan is not satisfactory.
干预措施: Ranitidine (Drug)
Nefopam
Premedication of IV (Intravenous)10mg Metoclopramide and 50mg Ranitidine would be given morning of surgery to all patients.
0.15mg/kg of Acupan(Nefopam) would be administered IV after the initiation of the subarachnoid block (Time 0) and presence and severity of shivering (the primary outcome) would be looked out for.
IV Ephedrine in 3mg alliquots would be given if hypotension occurs; IV oxytocin 30-50mg would be given after delivery of the baby to all patients and IV Pethidine 25mg would be given to abate any residual shivering if a repeat dose of Acupan is not satisfactory.
干预措施: Pethidine (Drug)
Nefopam
Premedication of IV (Intravenous)10mg Metoclopramide and 50mg Ranitidine would be given morning of surgery to all patients.
0.15mg/kg of Acupan(Nefopam) would be administered IV after the initiation of the subarachnoid block (Time 0) and presence and severity of shivering (the primary outcome) would be looked out for.
IV Ephedrine in 3mg alliquots would be given if hypotension occurs; IV oxytocin 30-50mg would be given after delivery of the baby to all patients and IV Pethidine 25mg would be given to abate any residual shivering if a repeat dose of Acupan is not satisfactory.
干预措施: Ephedrine (Drug)
Nefopam
Premedication of IV (Intravenous)10mg Metoclopramide and 50mg Ranitidine would be given morning of surgery to all patients.
0.15mg/kg of Acupan(Nefopam) would be administered IV after the initiation of the subarachnoid block (Time 0) and presence and severity of shivering (the primary outcome) would be looked out for.
IV Ephedrine in 3mg alliquots would be given if hypotension occurs; IV oxytocin 30-50mg would be given after delivery of the baby to all patients and IV Pethidine 25mg would be given to abate any residual shivering if a repeat dose of Acupan is not satisfactory.
干预措施: oxytocin (Drug)
Tramadol
Premedication of IV (Intravenous)10mg Metoclopramide and 50mg Ranitidine would be given morning of surgery to all patients.
1mg/kg of tramadol would be administered after the initiation of the subarachnoid block (Time 0) and presence and severity of shivering (the primary outcome) would be looked out for.
IV Ephedrine in 3mg alliquots would be given if hypotension occurs; IV oxytocin 30-50mg would be given after delivery of the baby to all patients and IV Pethidine 25mg would be given to abate any residual shivering if a repeat dose of Tramadol is not satisfactory.
干预措施: Tramadol (Drug)
Tramadol
Premedication of IV (Intravenous)10mg Metoclopramide and 50mg Ranitidine would be given morning of surgery to all patients.
1mg/kg of tramadol would be administered after the initiation of the subarachnoid block (Time 0) and presence and severity of shivering (the primary outcome) would be looked out for.
IV Ephedrine in 3mg alliquots would be given if hypotension occurs; IV oxytocin 30-50mg would be given after delivery of the baby to all patients and IV Pethidine 25mg would be given to abate any residual shivering if a repeat dose of Tramadol is not satisfactory.
干预措施: Metoclopramide (Drug)
Tramadol
Premedication of IV (Intravenous)10mg Metoclopramide and 50mg Ranitidine would be given morning of surgery to all patients.
1mg/kg of tramadol would be administered after the initiation of the subarachnoid block (Time 0) and presence and severity of shivering (the primary outcome) would be looked out for.
IV Ephedrine in 3mg alliquots would be given if hypotension occurs; IV oxytocin 30-50mg would be given after delivery of the baby to all patients and IV Pethidine 25mg would be given to abate any residual shivering if a repeat dose of Tramadol is not satisfactory.
干预措施: Ranitidine (Drug)
Tramadol
Premedication of IV (Intravenous)10mg Metoclopramide and 50mg Ranitidine would be given morning of surgery to all patients.
1mg/kg of tramadol would be administered after the initiation of the subarachnoid block (Time 0) and presence and severity of shivering (the primary outcome) would be looked out for.
IV Ephedrine in 3mg alliquots would be given if hypotension occurs; IV oxytocin 30-50mg would be given after delivery of the baby to all patients and IV Pethidine 25mg would be given to abate any residual shivering if a repeat dose of Tramadol is not satisfactory.
干预措施: Pethidine (Drug)
Tramadol
Premedication of IV (Intravenous)10mg Metoclopramide and 50mg Ranitidine would be given morning of surgery to all patients.
1mg/kg of tramadol would be administered after the initiation of the subarachnoid block (Time 0) and presence and severity of shivering (the primary outcome) would be looked out for.
IV Ephedrine in 3mg alliquots would be given if hypotension occurs; IV oxytocin 30-50mg would be given after delivery of the baby to all patients and IV Pethidine 25mg would be given to abate any residual shivering if a repeat dose of Tramadol is not satisfactory.
干预措施: Ephedrine (Drug)
Tramadol
Premedication of IV (Intravenous)10mg Metoclopramide and 50mg Ranitidine would be given morning of surgery to all patients.
1mg/kg of tramadol would be administered after the initiation of the subarachnoid block (Time 0) and presence and severity of shivering (the primary outcome) would be looked out for.
IV Ephedrine in 3mg alliquots would be given if hypotension occurs; IV oxytocin 30-50mg would be given after delivery of the baby to all patients and IV Pethidine 25mg would be given to abate any residual shivering if a repeat dose of Tramadol is not satisfactory.
干预措施: oxytocin (Drug)
结局指标
主要结局
Presence of Post anaesthetic shivering measured by the Crossley and Mahajan Scale
时间窗: 60 minutes
Presence of shivering following the subarachnoid block using the Crossley and Mahajan Scale 0 = no shivering 1. = no visible muscle activity but piloerection, peripheral vasoconstriction or both are present (other causes excluded) 2. = muscular activity in only one muscle group 3. = moderate muscular activity in more than one muscle group but no generalized shaking 4. = muscular activity that involves the whole body
Severity of Post Anaesthetic Shivering measured by th Crossley and Mahajan Scale
时间窗: 60 minutes
Severity of shivering where it occurs using the Crossley and Mahajan Scale 0 = no shivering 1. = no visible muscle activity but piloerection, peripheral vasoconstriction or both are present (other causes excluded) 2. = muscular activity in only one muscle group 3. = moderate muscular activity in more than one muscle group but no generalized shaking 4. = muscular activity that involves the whole body
次要结局
- Presence of Vomiting and Retching using Observation(60minutes)
- Change in Mean Arterial Pressure (MAP) in mmHg(60minutes)
研究者
Sarah Beckley
Dr
Lagos State Health Service Commission