Brain NeoplasmPhase 4NCT02964416
Single Dose Tramadol Effect on Extubation Response and Quality of Emergence Post-supratentorial Intracranial Surgery
A Phase 4 study testing Injection Tramadol in people with Brain Neoplasm, run by Aga Khan University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brain Neoplasm
- What is being tested?
- Injection Tramadol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- Mar 2016to Dec 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- Language barrier.
- Patients taking B-blockers or Ca channel blockers.
- Patients above 65 years of age ( Physiology difference)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Single Dose of Tramadol on Extubation Response and Quality of Emergence(Cough and Nausea Vomiting) Following 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.
Read the detailed description
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.
- Conditions
- Brain Neoplasm
- Being tested
- Injection Tramadol, placebo
- Keywords
- supratentorial craniotomy, extubation response, emergence, tramadol
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection TramadolDrug
Also called Tramal
placeboOther
Also called normal saline
0.9% Normal saline in 10 ml syringe
| Study group | Role | What they receive |
|---|---|---|
| Tramadol | Experimental | 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 Receives: Drug: Injection Tramadol |
| Placebo | Placebo comparator | 0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemodynamic Parameters at the Time of Emergence and Postextubation
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.
Measured: Systolic BP from the time of extubation till 6 hours post operatively
Haemodynamic Parameters at the Time of Emergence and Postextubation
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.
Measured: HR from the time of extubation till 6 hours post operatively
Haemodynamic Parameters at the Time of Emergence and Postextubation
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.
Measured: Diastolic BP from the time of extubation till 6 hours post operatively
Secondary outcomes (8)
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Cough on Cough Scale.
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.
Measured: Cough at the time of emergence
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Laryngospasm and Bronchospasm.
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
Measured: at the time of extubation till 6 hours postoperatively
Measure the Quality of Emergence From General Anaesthesia by Measuring Sedation Score
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)
Measured: at the time of extubation till 6 hours postoperatively
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring PONV
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
Measured: at Recovery Room , 2, 4 and 6 hours postoperatively
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring Convulsions
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.
Measured: at Recovery Room, 2, 4 and 6 hours postoperatively
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Monitoring GCS
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
Measured: at Recovery Room, 2, 4 and 6 hours postoperatively
Effect of Tramadol on Quality of Emergence Measured by Extubation Response Through Mointoring Requirement of Analgesia
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.
Measured: At Recovery room, 2, 4 and 6 hours postoperatively
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation
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
Measured: at the time of extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Brain NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asma Abdus Salam, Aga Khan University
- Investigators
- Asma A Salam, MCPS, FCPS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964416
- Sponsor's protocol ID
- 2954-Ane-ERC-14
- Status last verified
- Jul 2020
- First submitted
- 19 Sep 2016
- Last updated
- 4 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mikawa K, Nishina K, Maekawa N, Obara H. Attenuation of cardiovascular responses to tracheal extubation: verapamil versus diltiazem. Anesth Analg. 1996 Jun;82(6):1205-10. doi: 10.1097/00000539-199606000-00018.
PubMed 8638792Lin BF, Ju DT, Cherng CH, Hung NK, Yeh CC, Chan SM, Wu CT. Comparison between intraoperative fentanyl and tramadol to improve quality of emergence. J Neurosurg Anesthesiol. 2012 Apr;24(2):127-32. doi: 10.1097/ANA.0b013e31823c4a24.
PubMed 22089326Valley RD, Ramza JT, Calhoun P, Freid EB, Bailey AG, Kopp VJ, Georges LS. Tracheal extubation of deeply anesthetized pediatric patients: a comparison of isoflurane and sevoflurane. Anesth Analg. 1999 Apr;88(4):742-5. doi: 10.1097/00000539-199904000-00010.
PubMed 10195515Neelakanta G, Miller J. Minimum alveolar concentration of isoflurane for tracheal extubation in deeply anesthetized children. Anesthesiology. 1994 Apr;80(4):811-3. doi: 10.1097/00000542-199404000-00013.
PubMed 8024135Ferber J, Juniewicz H, Glogowska E, Wronski J, Abraszko R, Mierzwa J. Tramadol for postoperative analgesia in intracranial surgery. Its effect on ICP and CPP. Neurol Neurochir Pol. 2000;34(6 Suppl):70-9.
PubMed 11452859Sudheer PS, Logan SW, Terblanche C, Ateleanu B, Hall JE. Comparison of the analgesic efficacy and respiratory effects of morphine, tramadol and codeine after craniotomy. Anaesthesia. 2007 Jun;62(6):555-60. doi: 10.1111/j.1365-2044.2007.05038.x.
PubMed 17506732Rahimi SY, Alleyne CH, Vernier E, Witcher MR, Vender JR. Postoperative pain management with tramadol after craniotomy: evaluation and cost analysis. J Neurosurg. 2010 Feb;112(2):268-72. doi: 10.3171/2008.9.17689.
PubMed 19630495Lintz W, Beier H, Gerloff J. Bioavailability of tramadol after i.m. injection in comparison to i.v. infusion. Int J Clin Pharmacol Ther. 1999 Apr;37(4):175-83.
PubMed 10235420Salam AA, Rehman A, Shamim MS, Khan FA. Effect of tramadol on extubation response and quality of emergence following Supratentorial surgery: A randomised controlled trial. J Pak Med Assoc. 2022 Nov;72(11):2160-2165. doi: 10.47391/JPMA.4082.
PubMed 37013278
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Single Dose of Tramadol on Extubation Response and Quality of Emergence(Cough and Nausea Vomiting) Following Supratentorial Intracranial Surgery
- ClinicalTrials.gov ID
- NCT02964416
- Acronym / sponsor ID
- 2954-Ane-ERC-14
- Conditions
- Brain Neoplasm
- Keywords
- supratentorial craniotomy, extubation response, emergence, tramadol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Posted 4 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tramadol | Experimental | Drug: Injection TramadolInjection 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 |
| Placebo | Placebo comparator | Other: placebo0.9% Normal saline in 10 cc syringe,1ml/10kg via intravenous route, once at the time of dura closure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection TramadolAlso: Tramal | Drug | Tramadol |
| placeboAlso: normal saline0.9% Normal saline in 10 ml syringe | Other | Placebo |
Primary outcome
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.
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.
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.
8 secondary outcomes
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
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
Measure the Quality of Emergence From General Anaesthesia by Measuring Sedation Score
Time frame: at the time of extubation till 6 hours postoperatively
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
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
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
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
Measure the Quality of Emergence From General Anaesthesia by Measuring the Frequency of Episodes of Denaturation
Time frame: at the time of extubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8638792Mikawa K, Nishina K, Maekawa N, Obara H. Attenuation of cardiovascular responses to tracheal extubation: verapamil versus diltiazem. Anesth Analg. 1996 Jun;82(6):1205-10. doi: 10.1097/00000539-199606000-00018.
- Background: PubMed 22089326Lin BF, Ju DT, Cherng CH, Hung NK, Yeh CC, Chan SM, Wu CT. Comparison between intraoperative fentanyl and tramadol to improve quality of emergence. J Neurosurg Anesthesiol. 2012 Apr;24(2):127-32. doi: 10.1097/ANA.0b013e31823c4a24.
- Background: PubMed 10195515Valley RD, Ramza JT, Calhoun P, Freid EB, Bailey AG, Kopp VJ, Georges LS. Tracheal extubation of deeply anesthetized pediatric patients: a comparison of isoflurane and sevoflurane. Anesth Analg. 1999 Apr;88(4):742-5. doi: 10.1097/00000539-199904000-00010.
- Background: PubMed 8024135Neelakanta G, Miller J. Minimum alveolar concentration of isoflurane for tracheal extubation in deeply anesthetized children. Anesthesiology. 1994 Apr;80(4):811-3. doi: 10.1097/00000542-199404000-00013.
- Background: PubMed 11452859Ferber J, Juniewicz H, Glogowska E, Wronski J, Abraszko R, Mierzwa J. Tramadol for postoperative analgesia in intracranial surgery. Its effect on ICP and CPP. Neurol Neurochir Pol. 2000;34(6 Suppl):70-9.
- Background: PubMed 17506732Sudheer PS, Logan SW, Terblanche C, Ateleanu B, Hall JE. Comparison of the analgesic efficacy and respiratory effects of morphine, tramadol and codeine after craniotomy. Anaesthesia. 2007 Jun;62(6):555-60. doi: 10.1111/j.1365-2044.2007.05038.x.
- Background: PubMed 19630495Rahimi SY, Alleyne CH, Vernier E, Witcher MR, Vender JR. Postoperative pain management with tramadol after craniotomy: evaluation and cost analysis. J Neurosurg. 2010 Feb;112(2):268-72. doi: 10.3171/2008.9.17689.
- Background: PubMed 10235420Lintz W, Beier H, Gerloff J. Bioavailability of tramadol after i.m. injection in comparison to i.v. infusion. Int J Clin Pharmacol Ther. 1999 Apr;37(4):175-83.
- Derived from this study: PubMed 37013278Salam AA, Rehman A, Shamim MS, Khan FA. Effect of tramadol on extubation response and quality of emergence following Supratentorial surgery: A randomised controlled trial. J Pak Med Assoc. 2022 Nov;72(11):2160-2165. doi: 10.47391/JPMA.4082.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asma A Salam, MCPS, FCPS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Injection Tramadol in people with Brain Neoplasm, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemodynamic Parameters at the Time of Emergence and Postextubation (time frame: Systolic BP from the time of extubation till 6 hours post operatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02964416, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.