Timing of Rocuronium After Induction With Propofol on Temporal Summation of Pain

NCT ID: NCT04547608

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-09-04

Brief Summary

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Temporal summation of pain, which is defined as the perception of increasingly greater pain evoked by repetitive painful stimuli, is highly variable between individuals. This study aimed to determine the impact of the timing of rocuronium after induction with propofol on temporal summation of pain in gynecologic laparoscopic surgery.

Detailed Description

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Conditions

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Gynecological Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One hundred patients, between 18-60 years of age were randomly assigned to one of the two groups; group PRi received immediate injection of rocuronium after propofol administration, and group PRd received rocuronium injection when bispectral index score became below 60 after propofol administration
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Attending anesthesiologist knew which anesthetic agents were used. However Outcomes assessor didn't know which anesthetic agents were used.

Study Groups

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group PRi

received immediate injection of rocuronium after propofol administration,

Group Type OTHER

The difference of the timing of rocuronium administration after propofol injection

Intervention Type OTHER

The difference of the timing was rocuronium was administered immediately after propofol injection or when BIS score became below 60 after propofol administration.

group PRd

rocuronium injection when bispectral index score became below 60 after propofol administration

Group Type OTHER

The difference of the timing of rocuronium administration after propofol injection

Intervention Type OTHER

The difference of the timing was rocuronium was administered immediately after propofol injection or when BIS score became below 60 after propofol administration.

Interventions

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The difference of the timing of rocuronium administration after propofol injection

The difference of the timing was rocuronium was administered immediately after propofol injection or when BIS score became below 60 after propofol administration.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Elective gynecologic laparoscopic surgery
* American Society of Anesthesiologists' physical status class) I-II

Exclusion Criteria

* Menopause (to exclude the hormonal effect on pain)
* Patients who had muscular, cardiovascular, hepatic or kidney disorders and patients with a history of medication who would affect muscle relaxants were excluded from this study.
* Patients with difficult venous access on forearm, a known allergy to propofol or rocuronium, chronic pain, pregnancy, and those who had received analgesics or sedatives within the previous 24 hours, were excluded from the study.
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wonkwang University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cheol Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cheol Lee, M.D,Ph.D

Role: STUDY_DIRECTOR

Department of anesthesiology and pain medicine

Locations

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WonwangUH

Iksan, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

References

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Cheng JC, Erpelding N, Kucyi A, DeSouza DD, Davis KD. Individual Differences in Temporal Summation of Pain Reflect Pronociceptive and Antinociceptive Brain Structure and Function. J Neurosci. 2015 Jul 1;35(26):9689-700. doi: 10.1523/JNEUROSCI.5039-14.2015.

Reference Type BACKGROUND
PMID: 26134651 (View on PubMed)

Ayoglu H, Altunkaya H, Ozer Y, Yapakci O, Cukdar G, Ozkocak I. Does dexmedetomidine reduce the injection pain due to propofol and rocuronium? Eur J Anaesthesiol. 2007 Jun;24(6):541-5. doi: 10.1017/S0265021506002250. Epub 2007 Jan 23.

Reference Type BACKGROUND
PMID: 17241503 (View on PubMed)

Hwang SM, Cho SH, Lim SY, et al. The efficacy of BIS monitoring for the preventing of withdrawal movement on the intravenous injection of rocuronium. Korean J Anesthesiol 2005;49:293-7.

Reference Type BACKGROUND

Lim BG, Lee IO, Kim YS, Won YJ, Kim H, Kong MH. The utility of bispectral index monitoring for prevention of rocuronium-induced withdrawal movement in children: A randomized controlled trial. Medicine (Baltimore). 2017 Jan;96(2):e5871. doi: 10.1097/MD.0000000000005871.

Reference Type BACKGROUND
PMID: 28079825 (View on PubMed)

Other Identifiers

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WonkwangUH7

Identifier Type: -

Identifier Source: org_study_id

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