NCT02416752

Brief Summary

Opioid tolerance in the perioperative period is inevitable especially with ultra-short acting agents such as remifentanil. Existing evidence had shown that opioid induced hyperalgesia due to neuroplastic changes in the central as well as peripheral nervous system leads to sensitization of pro-nociceptive pathways. However there has been a controversy of occurrence of such tolerance following the use of remifentanil and the quality of recovery as compared to conventional opioids. The investigators evaluated the occurrence of opioid tolerance and other significant adverse effects with remifentanil in subjects undergoing head and neck surgeries. The investigators studied ASA physical status I and II adult subjects undergoing elective head and neck procedures, under general anesthesia with minimum expected duration of 2 hours. The remifentanil infusion was used in one group and intermittent boluses of morphine or fentanyl administered in another group. They were evaluated for immediate post-operative pain by using numerical rating scale (NRS), the opioid consumption, post-operative nausea, vomiting, other significant adverse effects of remifentanil and the time to discharge from PACU.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

1.9 years

First QC Date

April 7, 2015

Last Update Submit

April 14, 2015

Conditions

PainHead and Neck Disorder

Keywords

remifentanilhead and neck surgeryrecovery pofileOpioid induced hyperalgesiapost operative pain

Outcome Measures

Primary Outcomes (1)

  • Amount of opioids used in PACU in morphine equivalent

    average time spent in PACU

    90 minutes

Secondary Outcomes (2)

  • Duration of PACU

    90 minutes

  • Adverse effects of remifentanil

    90 minutes

Study Arms (2)

remifentanil group

Group received intra op remifentanil infusion

Drug: Remifentanil

conventional opioid gropup

Group received only conventional opioids and No infusion of remifentanil

Drug: choice of intra-operative opioids were left to the discretion of anesthesiologist

Interventions

RemifentanilDRUG

The remifentanil infusion was used intra operatively in remifentanil group and intermittent boluses of morphine or fentanyl administered for conventional opioid group

remifentanil group
choice of intra-operative opioids were left to the discretion of anesthesiologistDRUG
conventional opioid gropup

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We studied 222 adult subjects between 21 and 80 years, over two years at Singapore General Hospital, Singapore. All subjects were ASA I to II and scheduled for elective head and neck surgery with minimum expected duration of 2 hours, requiring general anesthesia.

You may qualify if:

  • Patients with ASA I to II, scheduled for elective head and neck surgery with minimum expected duration of 2 hours, requiring general anesthesia

You may not qualify if:

  • previous history of either drug or alcohol abuse those who have been using opioids for long term mental disorder with difficult to understand pain scoring system ASA physical status of III and above surgical procedure warranting elective postoperative ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia Singapore General Hospital

Singapore, 169608, Singapore

Location

Related Publications (10)

  • Thompson JP, Rowbotham DJ. Remifentanil--an opioid for the 21st century. Br J Anaesth. 1996 Mar;76(3):341-3. doi: 10.1093/bja/76.3.341. No abstract available.

    PMID: 8785129RESULT

  • Kaygusuz K, Yildirim A, Kol IO, Gursoy S, Mimaroglu C. Hypotensive anaesthesia with remifentanil combined with desflurane or isoflurane in tympanoplasty or endoscopic sinus surgery: a randomised, controlled trial. J Laryngol Otol. 2008 Jul;122(7):691-5. doi: 10.1017/S0022215107001545. Epub 2008 Feb 21.

    PMID: 18289455RESULT

  • Manola M, De Luca E, Moscillo L, Mastella A. Using remifentanil and sufentanil in functional endoscopic sinus surgery to improve surgical conditions. ORL J Otorhinolaryngol Relat Spec. 2005;67(2):83-6. doi: 10.1159/000084576. Epub 2005 Mar 22.

    PMID: 15785115RESULT

  • Guignard B, Bossard AE, Coste C, Sessler DI, Lebrault C, Alfonsi P, Fletcher D, Chauvin M. Acute opioid tolerance: intraoperative remifentanil increases postoperative pain and morphine requirement. Anesthesiology. 2000 Aug;93(2):409-17. doi: 10.1097/00000542-200008000-00019.

    PMID: 10910490RESULT

  • Joly V, Richebe P, Guignard B, Fletcher D, Maurette P, Sessler DI, Chauvin M. Remifentanil-induced postoperative hyperalgesia and its prevention with small-dose ketamine. Anesthesiology. 2005 Jul;103(1):147-55. doi: 10.1097/00000542-200507000-00022.

    PMID: 15983467RESULT

  • Lee M, Silverman SM, Hansen H, Patel VB, Manchikanti L. A comprehensive review of opioid-induced hyperalgesia. Pain Physician. 2011 Mar-Apr;14(2):145-61.

    PMID: 21412369RESULT

  • Yeom JH, Kim KH, Chon MS, Byun J, Cho SY. Remifentanil used as adjuvant in general anesthesia for spinal fusion does not exhibit acute opioid tolerance. Korean J Anesthesiol. 2012 Aug;63(2):103-7. doi: 10.4097/kjae.2012.63.2.103. Epub 2012 Aug 14.

    PMID: 22949975RESULT

  • Lee LH, Irwin MG, Lui SK. Intraoperative remifentanil infusion does not increase postoperative opioid consumption compared with 70% nitrous oxide. Anesthesiology. 2005 Feb;102(2):398-402. doi: 10.1097/00000542-200502000-00024.

    PMID: 15681957RESULT

  • Komatsu R, Turan AM, Orhan-Sungur M, McGuire J, Radke OC, Apfel CC. Remifentanil for general anaesthesia: a systematic review. Anaesthesia. 2007 Dec;62(12):1266-80. doi: 10.1111/j.1365-2044.2007.05221.x.

    PMID: 17991265RESULT

  • von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Bull World Health Organ. 2007 Nov;85(11):867-72. doi: 10.2471/blt.07.045120.

    PMID: 18038077RESULT

MeSH Terms

Conditions

PainPain, Postoperative

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior resident

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 15, 2015

Study Start

August 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

SG(1)