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Trial record 5 of 28 for:    mahajan

Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering

This study is not yet open for participant recruitment.
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Verified August 2017 by Sarah Beckley, Lagos State Health Service Commission
Sponsor:
Information provided by (Responsible Party):
Sarah Beckley, Lagos State Health Service Commission
ClinicalTrials.gov Identifier:
NCT02441673
First received: May 1, 2015
Last updated: August 31, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention Phase
Post Anaesthetic Shivering Drug: Nefopam Drug: Tramadol Drug: Metoclopramide Drug: Ranitidine Drug: Pethidine Drug: Ephedrine Drug: oxytocin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering Following Subarachnoid Block

Resource links provided by NLM:


Further study details as provided by Sarah Beckley, Lagos State Health Service Commission:

Primary Outcome Measures:
  • Presence of Post anaesthetic shivering measured by the Crossley and Mahajan Scale [ Time Frame: 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 [ Time Frame: 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


Secondary Outcome Measures:
  • Presence of Vomiting and Retching using Observation [ Time Frame: 60minutes ]
    Presence or absence of vomiting or retching after administration of the intervention drug

  • Change in Mean Arterial Pressure (MAP) in mmHg [ Time Frame: 60minutes ]
    Blood Pressure measurement (systolic and diastolic) with the MAP would be measured every 5minutes throughout the 60minutes study duration


Estimated Enrollment: 130
Anticipated Study Start Date: October 2017
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.

Drug: Nefopam
Nefopam 0.15mg/kg would be made up to 10mls using sterile water for injection
Other Name: Acupan
Drug: Metoclopramide
10mg would be given morning of surgery as a prokinetic premedication for all patients.
Drug: Ranitidine
50mg would be given to each patient morning of surgery as a premedicant to reduce the acidity of the gastric contents. It is routine for CS.
Drug: Pethidine
25mg would be used to stop shivering where a repeat dose of the primary intervention drugs have not been effective.
Drug: Ephedrine
A vasopressor. Would be used to combat any hypotension that occurs due to the neuroaxial block. Would be used in aliquots of 3mg.
Drug: oxytocin
Would be used for all patients following delivery of the baby to aid contraction of the uterus.
Active Comparator: 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.

Drug: Tramadol
Tramadol 1mg/kg would be made up to 10mls using sterile water for injection
Drug: Metoclopramide
10mg would be given morning of surgery as a prokinetic premedication for all patients.
Drug: Ranitidine
50mg would be given to each patient morning of surgery as a premedicant to reduce the acidity of the gastric contents. It is routine for CS.
Drug: Pethidine
25mg would be used to stop shivering where a repeat dose of the primary intervention drugs have not been effective.
Drug: Ephedrine
A vasopressor. Would be used to combat any hypotension that occurs due to the neuroaxial block. Would be used in aliquots of 3mg.
Drug: oxytocin
Would be used for all patients following delivery of the baby to aid contraction of the uterus.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02441673

Contacts
Contact: Sarah Beckley, MBBS,MPH,DA, +2348033086024 hijeh00@yahoo.com

Sponsors and Collaborators
Lagos State Health Service Commission
Investigators
Study Director: Maria Akintimoye Lagos State HealthService Commission
  More Information

Responsible Party: Sarah Beckley, Dr, Lagos State Health Service Commission
ClinicalTrials.gov Identifier: NCT02441673     History of Changes
Other Study ID Numbers: SAS/15/01
Study First Received: May 1, 2015
Last Updated: August 31, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sarah Beckley, Lagos State Health Service Commission:
Postanaesthetic shivering
Subarachnoid block
Tramadol
Nefopam

Additional relevant MeSH terms:
Anesthetics
Oxytocin
Tramadol
Meperidine
Nefopam
Metoclopramide
Ranitidine bismuth citrate
Ranitidine
Ephedrine
Pseudoephedrine
Central Nervous System Depressants
Physiological Effects of Drugs
Oxytocics
Reproductive Control Agents
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Sympathomimetics
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on September 21, 2017