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General Anesthesia With PropofolPhase 2NCT03134612

Comparison Between Ondansetron 8 mg and Lidocain 40 mg in Preventing Pain Due to Propofol Injection

A Phase 2 study testing Ondansetron 8 mg and Lidocain 40 mg in people with General Anesthesia With Propofol, run by Universitas Indonesia at 1 site in Indonesia.

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

This study aims to compare the effectivity between ondansetron 8 mg and lidocain 40 mg in preventing pain due to propofol injection Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
General Anesthesia With Propofol
What is being tested?
Ondansetron 8 mg and Lidocain 40 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteIndonesia
Study dates
Jul 2016to Sep 2016
Phase
Phase 2
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects aged 18-65 years old
  • Subjects were planned to undergo general anesthesia with propofol
  • Subjects with Body Mass Index (BMI) 18-35 kg/m2
  • Subjects with American Society of Anesthesiologists (ASA) physical status of I-II
  • Subjects with signed informed consent.

Who cannot join

  • Subjects with allergies to propofol, lidocain, ondansetron
  • Subjects with massive cardiac disorder
  • Subjects with cardiac rhythm disorder with or without treatment
  • Subjects with unstable hemodynamic
  • Subjects with contraindication to propofol, lidocain, ondansetron
  • Subjects with intubation and ventilation difficulty
Show all 15Show fewer
  • Subjects with decreased consciousness, seizure history or head injury
  • Subjects with analgesic treatment history
  • Subjects with pregnancy.
  • Drop out criteria:
  • Subjects with allergic reactions induced by propofol, lidocain, ondansetron
  • Uncooperative subjects
  • Subjects in emergency
  • Subjects with difficult vein access in the dorsum manus
  • Subjects with infection and/or inflammation in the planned intravenous cannulation location.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Cipto Mangunkusumo Central National Hospital

    Jakarta, DKI Jakarta, 10430

Other trials in Indonesia

About this study

This study aims to compare the effectivity between ondansetron 8 mg and lidocain 40 mg in preventing pain due to propofol injection

Read the detailed description

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Non-invasive blood pressure (NIBP) monitor, ECG and pulse-oximeter was set on the subjects in the operation room. After a tourniquet made from NIBP cuff were inflated, subjects were given either Ondansetron 8 mg or Lidocain 20 mg intravenously, then the tourniquet was set off. Hemodynamic data was recorded. Propofol 1 mg/kg of body weight (BW) injection was given. Verbal rating scale was used to measure pain at 0 s, 5 s and 30 s. Data was analyzed using Statistical Package for the Social Sciences (SPSS), for numeric data using uni-variate analysis and bi-variate analysis. Significant value is p<0.05.

Being tested
Ondansetron 8 mg, Lidocain 40 mg
Keywords
lidocain, ondansetron, pain, propofol
Medical subject headings
Pain

What participants receive

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

  • Ondansetron 8 mgDrug

  • Lidocain 40 mgDrug

Study groups in NCT03134612
Study groupRoleWhat they receive
OndansetronActive comparatorOndansetron 8mg (2mg/cc) was given intravenously via a 20 G vein canula
Receives: Drug: Ondansetron 8 mg
LidocainActive comparatorLidocain 40mg (20mg/cc + 2cc of normal saline) was given intravenously via a 20 G vein canula
Receives: Drug: Lidocain 40 mg

What is being measured

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

  1. The Degree of pain due to Propofol Injection

    The degree of pain due to propofol injection was measured at 0 second, 15 seconds, 30 second, using verbal rating scale

    Measured: Day 1

Timeline

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

  1. First posted1 May 2017
  2. Study startJul 2016
  3. Primary completionSep 2016
  4. Study completionSep 2016

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 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03134612
Sponsor's protocol ID
IndonesiaUAnes005
Status last verified
Apr 2017
First submitted
24 Apr 2017
Last updated
1 May 2017
Results posted
No
Individual data sharing
Undecided

Publications

  • Marik PE. Propofol: therapeutic indications and side-effects. Curr Pharm Des. 2004;10(29):3639-49. doi: 10.2174/1381612043382846.

    PubMed 15579060

  • Jalota L, Kalira V, George E, Shi YY, Hornuss C, Radke O, Pace NL, Apfel CC; Perioperative Clinical Research Core. Prevention of pain on injection of propofol: systematic review and meta-analysis. BMJ. 2011 Mar 15;342:d1110. doi: 10.1136/bmj.d1110.

    PubMed 21406529

  • Tan CH, Onsiong MK. Pain on injection of propofol. Anaesthesia. 1998 May;53(5):468-76. doi: 10.1046/j.1365-2044.1998.00405.x.

    PubMed 9659020

  • Johnson RA, Harper NJ, Chadwick S, Vohra A. Pain on injection of propofol. Methods of alleviation. Anaesthesia. 1990 Jun;45(6):439-42. doi: 10.1111/j.1365-2044.1990.tb14328.x.

    PubMed 2200299

  • Macario A, Weinger M, Truong P, Lee M. Which clinical anesthesia outcomes are both common and important to avoid? The perspective of a panel of expert anesthesiologists. Anesth Analg. 1999 May;88(5):1085-91. doi: 10.1097/00000539-199905000-00023.

    PubMed 10320175

  • Ye JH, Mui WC, Ren J, Hunt TE, Wu WH, Zbuzek VK. Ondansetron exhibits the properties of a local anesthetic. Anesth Analg. 1997 Nov;85(5):1116-21. doi: 10.1097/00000539-199711000-00029.

    PubMed 9356111

  • Lee SK. Pain on injection with propofol. Korean J Anesthesiol. 2010 Nov;59(5):297-8. doi: 10.4097/kjae.2010.59.5.297. Epub 2010 Nov 25. No abstract available.

    PubMed 21179288

  • Massad IM, Abu-Ali HM, Abu-Halaweh SA, Badran IZ. Venous occlusion with lidocaine for preventing propofol induced pain. A prospective double-blind randomized study. Saudi Med J. 2006 Jul;27(7):997-1000.

    PubMed 16830018

  • Picard P, Tramer MR. Prevention of pain on injection with propofol: a quantitative systematic review. Anesth Analg. 2000 Apr;90(4):963-9. doi: 10.1097/00000539-200004000-00035.

    PubMed 10735808

  • Mangar D, Holak EJ. Tourniquet at 50 mm Hg followed by intravenous lidocaine diminishes hand pain associated with propofol injection. Anesth Analg. 1992 Feb;74(2):250-2. doi: 10.1213/00000539-199202000-00014.

    PubMed 1731546

  • Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002.

    PubMed 24356162

  • Tramer MR, Reynolds DJ, Moore RA, McQuay HJ. Efficacy, dose-response, and safety of ondansetron in prevention of postoperative nausea and vomiting: a quantitative systematic review of randomized placebo-controlled trials. Anesthesiology. 1997 Dec;87(6):1277-89. doi: 10.1097/00000542-199712000-00004.

    PubMed 9416710

  • Paventi S, Santevecchi A, Ranieri R. Efficacy of a single-dose ondansetron for preventing post-operative nausea and vomiting after laparoscopic cholecystectomy with sevoflurane and remifentanil infusion anaesthesia. Eur Rev Med Pharmacol Sci. 2001 Mar-Apr;5(2):59-63.

    PubMed 11863320

  • Azimaraghi O, Aghajani Y, Molaghadimi M, Khosravi M, Eslami K, Ghadimi F, Movafegh A. Ondansetrona reduz a dor da injecao de etomidato: estudo randomico controlado. Braz J Anesthesiol. 2014 May-Jun;64(3):169-72. doi: 10.1016/j.bjan.2013.06.014. Epub 2014 Mar 7. No abstract available. Portuguese.

    PubMed 25456475

  • Ambesh SP, Dubey PK, Sinha PK. Ondansetron pretreatment to alleviate pain on propofol injection: a randomized, controlled, double-blinded study. Anesth Analg. 1999 Jul;89(1):197-9. doi: 10.1097/00000539-199907000-00035.

    PubMed 10389803

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ondansetron 8 mg and Lidocain 40 mg in people with General Anesthesia With Propofol, run by Universitas Indonesia at 1 site in Indonesia.

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 5 inclusion and 15 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 1 May 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 Indonesia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The Degree of pain due to Propofol Injection (time frame: Day 1). 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 NCT03134612, which also lists 35 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 1 May 2017.

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