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NCT Number: NCT02964416

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aga Khan University

Karachi, Sindh, 74800, Pakistan

About this study

Extubation after intracranial tumor surgery is desirable in order to make an early diagnosis of intracranial complications. Extubation however, may be associated with haemodynamic and metabolic changes e.g. agitation, increased oxygen consumption, catecholamine secretion, hypercapnia and systemic hypertension.

These changes cause cerebral hyperemia, intracranial hypertension leading to cerebral oedema or haemorrhage, thus it is important to have smooth extubation with minimal haemodynamic and metabolic effects.

Incidence of coughing on emergence from general anesthesia ranges from 38% to 96%. This may also result in postoperative intracranial hemorrhage, intracranial hypertension, cerebral edema or intraocular hypertension.This can be detrimental in neurosurgery.

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.

Tramadol, a synthetic opioid of the aminocyclohexanes group, is a centrally acting opioid analgesic that is used to treat moderate-to-severe pain and has an inhibitory effect on M1 and M3 muscarinic receptors. It also reduces the incidence of cough and improves extubation quality, and provides more stable haemodynamics during emergence. It neither causes respiratory depression, nor affects intracranial pressure (ICP) and cerebral perfusion pressure (CPP). Other potential advantage of administering tramadol includes a long duration of action, rapid recovery, limited depression of respiratory function and no effect on platelets thus making it a safe medication to use for neurosurgical patients after craniotomy. The onset of effect following a single dose is 3 to 5 minutes with peak effect at 45 minutes.

Aim of doing this study is to observe the effect of a single dose of tramadol on quality of tracheal extubation as judged by incidence of coughing and haemodynamic changes at emergence from anesthesia.

OBJECTIVE:

Primary Objective: To observe the effect of single dose of tramadol (1mg/kg) administered 45 minutes before extubation on haemodynamic response (measurement of B.P and H.R) during extubation.

Secondary Objective: To measure the quality of emergence from general anaesthesia by measuring the frequency of cough, laryngospasm and episodes of desaturation.

OPERATIONAL DEFINITION:

Emergence Period: This will be defined as the time from the recovery of spontaneous breathing after giving reversal to tracheal extubation.

Quality of emergence: Good quality emergence will be defined as extubation not associated with coughing, bucking, tachycardia, hypertension, laryngospasm or bronchospasm.

Tachycardia and hypertension: Rise in heart rate and blood pressure more than 20% from baseline value.

Extubation response: Physiological response related to blood pressure and heart rate during extubation of trachea is called extubation response,

HYPOTHESIS:

Tramadol obtunds haemodynamic and cough response to extubation and thus results in good quality emergence after supratentorial craniotomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Injection Tramadol

Drug

Other names: Tramal

Placebo

Other

0.9% Normal saline in 10 ml syringe

Other names: normal saline

Primary outcomes

  1. Haemodynamic Parameters at the Time of Emergence and Postextubation

    Time frame: Systolic BP from the time of extubation till 6 hours post operatively

    Systolic 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: HR 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.

  3. Haemodynamic Parameters at the Time of Emergence and Postextubation

    Time frame: Diastolic BP from the time of extubation till 6 hours post operatively

    Diastolic 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.

Secondary outcomes

  1. Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale.

    Time frame: Cough at the time of emergence

    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 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)

  4. Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV

    Time frame: at Recovery Room , 2, 4 and 6 hours postoperatively

    Post operative nausea vomiting will be recorded at RR, 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

  5. Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions

    Time frame: at Recovery Room, 2, 4 and 6 hours postoperatively

    Convulsions will be recorded at Recovery Room, 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.

  6. Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS

    Time frame: at Recovery Room, 2, 4 and 6 hours postoperatively

    Post operative Glasgow Coma Scale (GCS) will be recorded at Recovery Room, 2, 4 and 6 hours postoperatively. If there is any deterioration in GCS less than 8/15, Patients will be intubated.

    GCS categories <8 Low GCS 9-12 Intermediate GCS 13-15 Full GCS

  7. Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia

    Time frame: At Recovery room, 2, 4 and 6 hours postoperatively

    Requirement of analgesia will be recorded at recovery room, 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.

  8. Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation

    Time frame: at the time of extubation

    If there is any episodes of denaturation (Oxygen saturation <92%), it will be noted it it is occurring during emergence.

    Absence of it will be considered as smooth emergence

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study title

Effect of Single Dose of Tramadol on Extubation Response and Quality of Emergence(Cough and Nausea Vomiting) Following Supratentorial Intracranial Surgery

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 16, 2016
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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