Effect of deep neuromuscular paralysis on the force required during dissection of the latissimus dorsi muscle for reconstructive breast surgery: a randomized blinded trial.

Effect of deep muscle relaxation with rocuronium versus administration of saline on the force required during dissection of the latissimus dorsi muscle for reconstructive breast surgery: a randomized blinded trial

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000637640

Acronym

none

Enrollment

Registered

2014-06-17

Start date

2013-06-25

Completion date

2014-05-20

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The effect of muscle relaxation on latissimus dorsi ease of flap dissection are unknown though the technique has frequently ben recommended. The purpose of the trial is to measure the facilitation of flap dissection by means of assessing the force (N) required to lift the flap a few centimetres off its surface, thus mimicking surgical handling of the flap. The measurement is done with a sterile scale. 3 measurements will be done: 1. baseline, 2. after either rocuronium or saline administration intravenously, and 3. after administration of the drug (rocuronium or saline) not yet given at 2.. The measurement will be done by a researcher blinded to the administration sequence of the drugs.

Interventions

Intravenous administration of a single dose of the muscle relaxant rocuronium (0.6 mg/kg) or 5 ml normal saline during latissimus dorsi flap dissection and measurement of force (N) required to lift the muscle a specific distance off its bed. The order of drug administration (rocuronium or saline) follows a randomization protocol, but requires no washout phase.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Female patients scheduled for elective breast reconstructive surgery with a latissimus dorsi flap.

Exclusion criteria

incapacity to or declining to consent, allergy to rocuronium, neuromuscular disorder or stroke with ongoing paralysis, ongoing treatment with muscle relaxing substances.

Outcome results