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Delayed Emergence From AnesthesiaPhase 4NCT02602743

Propofol-Ketamine vs Remifentanyl-Ketamine for Sedation in Pediatric Patients Undergoing Colonoscopy

A Phase 4 study testing Remifentanyl, Propofol and Ketamine in people with Delayed Emergence From Anesthesia, run by Cukurova University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Ketamine and propofol have been used most frequently agents and remifentanil is used with increasing frequency in recent years. Investigators will compare ketamine-propofol and ketamine-remifentanyl effects on drug consumption, respiration, hemodynamics and recovery in pediatric colonoscopy patients. Read more about this study

Who is it for?
Ages 2 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Delayed Emergence From Anesthesia
What is being tested?
Remifentanyl, Propofol and Ketamine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
Aug 2016to Jan 2017
Phase
Phase 4
Are there results?
None posted in the registry

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 2 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • ASA I-II
  • 2-16 years old children

Who cannot join

  • Children with cardiovascular disease,
  • Children with cerebral disorder, respiratory disease,
  • Children with renal failure
  • Children with hepatic failure

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Cukurova University Faculty of Medicine Research Hospital

    Adana

Other trials in Turkey (Türkiye)

About this study

Ketamine and propofol have been used most frequently agents and remifentanil is used with increasing frequency in recent years. Investigators will compare ketamine-propofol and ketamine-remifentanyl effects on drug consumption, respiration, hemodynamics and recovery in pediatric colonoscopy patients. Our study is a prospective, randomized comparison of ketamine-propofol and remifentanyl-propofol for sedation in pediatric patients during elective colonoscopy. ASA I-II, 2-16 years old, seventy children will be included in the study after ethics committee approval and written informed consent from the parents. Children with cardiovascular, cerebral, pulmonary, renal and hepatic diseases will be excluded from the study. Group I (RK); 2 mg/kg ketamine and 0,25 µg/kg remifentanyl will be administered for induction in 1 minute.Then 0,1 µg/kg/h remifentanyl infusion will be started.

Group II (PK); 2 mg/kg ketamine and 1 mg/kg propofol will be administered for induction and then 1 mg/kg/h propofol infusion will be started. In case of movement, crying, heart rate and systolic blood pressure more than 20% increase from baseline; 0.05 to 0.1 mg / kg of remifentanil will be administered in group I, 0.5-1 mg / kg will be administered propofol in group II. Not enough that case 0.5-1 mg / kg of ketamine will be applied.

The anesthesiologist will continue monitoring after completion of colonoscopy until recovery of full consciousness. A Steward recovery score of 7 will be defined as the end of the recovery time.

Read the detailed description

Optimal drug combinations for sedation and analgesia for the diagnosis and treatment of interventional procedures performed in pediatric patients still continue to be the main subject of many scientific studies. The drugs used for this purpose have advantages and disadvantages against each other. Ketamine and propofol have been used most frequently agents and remifentanil is used with increasing frequency in recent years. Investigators will compare ketamine-propofol and ketamine-remifentanyl effects on drug consumption, respiration, hemodynamics and recovery in pediatric colonoscopy patients. Our study is a prospective, randomized comparison of ketamine-propofol and remifentanyl-propofol for sedation and analgesia in pediatric patients during elective colonoscopy. ASA I-II, 2-16 years old, seventy children will included in the study after ethics committee approval and written informed consent from the parents. Children with cardiovascular, cerebral, pulmonary, renal and hepatic diseases will excluded from the study. Patients will be divided into two groups randomly. Patients will fast for at least 6 hours and have an i.v. line in place for the duration of sedation and recovery. All patients will be administered 0,5 mg/kg midazolam orally for premedication 30 minutes before the procedure. Heart rate, systolic and diastolic arterial pressure, peripheral oxygen saturation, respiratory rate and Ramsay sedation scores of all of patients will recorded at baseline, after induction and every 5 minutes during the procedure by the anesthesiologist. All of the patients will receive oxygen (2-4 L/min) through a nasal cannula and 10 ml/kg/h crystalloid infusion perioperatively. The level of recovery at the end of the procedure will be evaluated by Steward Recovery Score.

Group I (RK); 2 mg/kg ketamine and 0,25 µg/kg remifentanyl will be administered for induction in 1 minute. Then 0,1 µg/kg/h remifentanyl infusion will be started.

Group II (PK); 2 mg/kg ketamine and 1 mg/kg propofol will be administered for induction and then 1 mg/kg/h propofol infusion will be started.

In case of movement, crying, heart rate and systolic blood pressure more than 20% increase from baseline; 0.05 to 0.1 mg / kg of remifentanil will be administered in group I, 0.5-1 mg / kg will be administered propofol in group II. Not enough that case 0.5-1 mg / kg of ketamine will be applied.

The anesthesiologist will continue monitoring after completion of colonoscopy until recovery of full consciousness. A Steward recovery score of 7 will be defined as the end of the recovery time. Throughout the process and during the postoperative observation, if systolic blood pressure more than 20% decrease from baseline will be applied 0,1 mg/kg ephedrine, if heart rate more than 20% decrease from baseline 0,01 mg/kg atropine will be applied.Colonoscopy time will be recorded. At the end of the procedure, the gastroenterologist will be asked to give a score in terms of ease attempt. (1=poor, 2=moderate, 3=good, 4=excellent) Adverse events will be recorded, including hypotension (decrease in blood pressure by 20% from baseline), hypertension (increase in blood pressure by 20% from baseline), bradycardia (decrease in heart rate by 20% from baseline), and hypoxia (oxygen desaturation with peripheral oxygen saturation <90%). In addition, the need for additional medication and operator satisfaction among will be compared to the among groups.

Being tested
Remifentanyl, Propofol, Ketamine
Keywords
sedation, remifentanyl, pediatric patient, colonoscopy
Medical subject headings
Delayed Emergence from Anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemifentanylDrug

    Also called Ultiva

    0,25 µg/kg remifentanyl will be administered for induction in 1 minute. Then 0,1 µg/kg/h remifentanyl infusion will be started.

  • PropofolDrug

    Also called Pofol

    1 mg/kg propofol will be administered for induction and then 1 mg/kg/h propofol infusion will be started.

  • KetamineDrug

    Also called Ketalar

    2 mg/kg ketamine will be administered for induction in 1 minute.

Study groups in NCT02602743
Study groupRoleWhat they receive
remifentanyl, ketamineExperimentalExperimental:Remifentanyl and ketamine Remifentanyl vial 2 mg, Ketamine vial 500mg/10 mlt by intravenous. 2 mg/kg ketamine and 0,25 µg/kg remifentanyl will be administered for induction in 1 minute. Then 0,1 µg/kg/h remifentanyl infusion will be started.
Receives: Drug: Remifentanyl; Drug: Ketamine
propofol, ketamineActive comparatorActive comparator:Propofol and ketamine Propofol injectable emulsion vial 200 mg/20 mlt, Ketamine vial 500mg/10 mlt by intravenous. 2 mg/kg ketamine and 1 mg/kg propofol will be administered for induction and then 1 mg/kg/h propofol infusion will be started.
Receives: Drug: Propofol; Drug: Ketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ketamine, remifentanyl, propofol consumption

    The amount of anesthetic used during colonoscopy will be recorded as milligram/kilogram for each patient.

    Measured: 1 hour

Secondary outcomes (3)
  1. Blood pressure

    Blood pressure will be followed during colonoscopy and until modified aldrete score will be 9 points.

    Measured: 1 hour

  2. Hypoxia

    Hypoxia (oxygen desaturation with peripheral oxygen saturation <90%) will be followed during colonoscopy and until modified aldrete score will be 9 points.

    Measured: 1 hour

  3. Heart rate

    Heart rate will be followed during colonoscopy and until modified aldrete score will be 9 points.

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2015 (estimated)
  2. Study startAug 2016
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02602743
Sponsor's protocol ID
PRK01
Status last verified
Feb 2017
First submitted
6 Nov 2015
Last updated
6 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Remifentanyl, Propofol and Ketamine in people with Delayed Emergence From Anesthesia, run by Cukurova University at 1 site in Turkey (Türkiye).

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 2 inclusion and 4 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 6 Feb 2017. 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 Turkey (Türkiye). 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Ketamine, remifentanyl, propofol consumption (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Feb 2017.

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