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Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial Intracranial Surgery

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ClinicalTrials.gov Identifier: NCT02964416
Recruitment Status : Unknown
Verified November 2016 by Asma Abdus Salam, Aga Khan University.
Recruitment status was:  Recruiting
First Posted : November 16, 2016
Last Update Posted : November 16, 2016
Sponsor:
Information provided by (Responsible Party):
Asma Abdus Salam, Aga Khan University

Brief Summary:
Several modalities have been studied to prevent coughing during emergence, including extubation in a deep plane of anesthesia but have proved to be unreliable. So far, no reliable method is recommended as standard of care. The advantages of administering tramadol includes a long duration of action, rapid recovery, limited depression of respiratory function and no effect on platelet makes it a safe medication to use for neurosurgical patients after craniotomy. The primary objective of the study is to observe the effect of single dose of tramadol (1mg/kg) administered 45 minutes before extubation on hemodynamic response (measurement of B.P and H.R) during extubation.

Condition or disease Intervention/treatment Phase
Brain Neoplasm Drug: Injection Tramadol Other: placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Single Dose of Tramadol on Extubation Response and Quality of Emergence(Cough and Nausea Vomiting) Following Supratentorial Intracranial Surgery
Study Start Date : March 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arm Intervention/treatment
Experimental: Tramadol
Injection Tramadol 100mg diluted in 10 cc syringe (10mg/ml) to be given as 1mg/kg or (1ml/10kg) via intravenous route, once, at the time of dura closure
Drug: Injection Tramadol
Other Name: Tramal

Placebo Comparator: Placebo
0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure
Other: placebo
0.9% Normal saline in 10 ml syringe
Other Name: normal saline




Primary Outcome Measures :
  1. Haemodynamic parameters at the time of emergence and postextubation [ Time Frame: from the time of extubation till 6 hours post operatively ]
    Blood pressure will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If values of blood pressure rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation.

  2. Haemodynamic parameters at the time of emergence and postextubation [ Time Frame: from the time of extubation till 6 hours post operatively ]
    Heart rate will be recorded at 1 minute before giving the reversal (glycopyrolate and neostigmine) and then 1,2,5,10,20,30 minutes ,1,2,4 and 6 hours after extubation. If haemodynamic values of heart rate rise more than 20% from baseline values injection Metoprolol 1mg (beta blocker) bolus will be used and titrated according to response. The study will end at 6 hours post extubation.


Secondary Outcome Measures :
  1. Measure the quality of emergence from general anaesthesia by measuring the frequency of cough on cough scale. [ Time Frame: at the time of extubation ]

    Cough will be described on following scale 5 = No coughing or straining, 4 = Very smooth minimal coughing, 3 = Moderate coughing, 2 = Marked coughing or straining,

    1 = Poor extubation

    Cough will be recorded on the above mentioned scale by resident/consultant at following time intervals of emergence

    • At resumption of spontaneous breathing,
    • Ability to respond to verbal commands
    • At cuff deflation
    • At extubation
    • 2 minutes after extubation. It will be noted if it occurs during emergence at the above mentioned time intervals. Absence of it will be considered as smooth emergence.

  2. Measure the quality of emergence from general anaesthesia by measuring the frequency of laryngospasm and bronchospasm. [ Time Frame: at the time of extubation till 6 hours postoperatively ]
    If there is any episode of bronchospasm or laryngospasm, it will be noted if it occured during emergence and for 6 hours post operatively. Absence of it will be considered as smooth emergence

  3. Measure the quality of emergence from general anaesthesia by measuring the frequency of episodes of desaturation. [ Time Frame: at the time of extubation till 6 hours postoperatively ]
    If there is any episode of desaturation (oxygen saturation <92%), it will be noted if it occurs during emergence and for 6 hours post operatively. Absence of it will be considered as smooth emergence.

  4. Measure the quality of emergence from general anaesthesia by measuring sedation score [ Time Frame: at the time of extubation till 6 hours postoperatively ]

    If there is any episode of sedation it will be noted if it occurs during emergence and for 6 hours post operatively. Absence of it will be considered as smooth emergence.

    sedation score will be used as 0= no sedation, 1= mildly sedated (eye opening on verbal commands), 2= moderately sedated ( awakens on giving pain), 3= deeply sedated ( not waking up even on pain)


  5. Effect of tramadol on quality of emergence measured by extubation response through monitoring PONV [ Time Frame: at 2, 4 and 6 hours postoperatively ]
    Post operative nausea vomiting will be recorded at 2, 4 and 6 hours postoperatively. If there is any episode of PONV it will be noted. Absence of it will be considered as smooth emergence

  6. Effect of tramadol on quality of emergence measured by extubation response through monitoring convulsions [ Time Frame: at 2, 4 and 6 hours postoperatively ]
    Convulsions will be recorded at 2, 4 and 6 hours postoperatively.If there is any episode of convulsion, it will be noted. Absence of it will be considered as smooth emergence.

  7. Effect of tramadol on quality of emergence measured by extubation response through monitoring GCS [ Time Frame: at 2, 4 and 6 hours postoperatively ]
    Post operative GCS will be recorded at 2, 4 and 6 hours postoperatively.If there is any deterioration in GCS, it will be noted. Full GCS will be considered as smooth emergence.

  8. Effect of tramadol on quality of emergence measured by extubation response through mointoring requirement of analgesia [ Time Frame: at 2, 4 and 6 hours postoperatively ]
    It will be recorded at 2, 4 and 6 hours postoperatively. If there is any need of analgesic, it will be noted and will be considered as one of the determinants of poor quality of emergence.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with craniotomy for supratentorial tumors under general anesthesia
  • American Society of Anaesthesiologists (ASA) 2 and stable ASA 3 patients
  • Elective surgery
  • Patients with Glasgow Coma Scale (GCS) 15/15

Exclusion Criteria:

  • Patients with a history of allergy or hypersensitivity to tramadol.
  • History of epilepsy or convulsions due to any reason.
  • Chronic usage of analgesic drugs.
  • Patients using monoamine oxidase inhibitors.
  • Patients with clinical signs of raised ICP.
  • Obesity (women with a body mass index >35 kg/m2 or men with a body mass index >42 kg/m2)
  • Language barrier.
  • Patients taking B-blockers or Ca channel blockers.
  • Patients above 65 years of age ( Physiology difference)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964416


Contacts
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Contact: Asma A Salam, MCPS, FCPS +922134864715 ext 4639 asma.salam@aku.edu
Contact: Fauzia A Khan +922134864639 ext 4637 fauzia.khan@aku.edu

Locations
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Pakistan
Aga Khan University Recruiting
Karachi, Sindh, Pakistan, 74800
Contact: Asma A Salam, MCPS, FCPS    +922134864639    asma.salam@aku.edu   
Contact: Fauzia A Khan, FRCA    +922134864639    fauzia.khan@aku.edu   
Sub-Investigator: Azhar Rehman, FCPS         
Sub-Investigator: Shahzad Shamim, FCPS         
Sub-Investigator: Fauzia A Khan, FRCA         
Sponsors and Collaborators
Aga Khan University
Investigators
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Principal Investigator: Asma A Salam, MCPS, FCPS Aga Khan University Hospital

Publications:

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Responsible Party: Asma Abdus Salam, Senior Instructor, Aga Khan University
ClinicalTrials.gov Identifier: NCT02964416     History of Changes
Other Study ID Numbers: 2954-Ane-ERC-14
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Asma Abdus Salam, Aga Khan University:
supratentorial craniotomy
extubation response
emergence
tramadol

Additional relevant MeSH terms:
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Tramadol
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents