Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04709315 |
| Other study ID # |
southvu7 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2020 |
| Est. completion date |
January 2021 |
Study information
| Verified date |
January 2021 |
| Source |
South Valley University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Background: Rapid sequence induction is a well-established anesthetic procedure used in
trauma setting and patients with full stomach. Succinyl choline has the been the drug of
choice, however, it carries potential risk and sometimes fatal outcome. Aim of the study: to
compare rocuronium after pre-treatment with Dexmedetomidine, to succinyl choline in providing
excellent intubating conditions. Material and method: Patients were randomly allocated to one
of two groups, of 120 each. Control (SS) group, patients received pretreatment with 10 ml
0.9% saline over 10 minutes, and succinyl choline 1mg/ kg was on induction. Experimental (DR)
group, received pretreatment with Dex 1 µg / kg in 10 ml 0.9% saline over 10 minutes and
rocuronium 0.6 mg/kg on induction.
Description:
Rapid sequence induction (RSI) is a well-established anesthetic procedure routinely used in
emergency and trauma setting, and in elective situations when there is high risk of
regurgitation/aspiration The ideal neuromuscular relaxant agent used for RSI should have a
quick onset of action, which is a major advantage in trauma setting as it mitigates the risk
of aspiration and desaturation when endotracheal intubation should be performed as early as
possible. It also should have a quick offset to ensure that if trials at endotracheal
intubation were unsuccessful, there would be quick neuromuscular recovery, with return to
spontaneous breathing before the patient start desaturation. Moreover, it should have minimal
cardiovascular or systemic side effects.
Typically, succinyl choline has been the neuromuscular agent of choice for RSI as it has the
quickest onset and offset of action compared to other muscle relaxants. However, it has
potentially risky- sometimes fatal- side effects that make it far from being ideal
neuromuscular blocking agent in RSI.
Owing to its fast onset of action and stable hemodynamics Rocuronium, a non-depolarizing
muscle blocker, has been suggested as possible alternative to succinyl choline in RSI. The
standard rocuronium intubating dose of during routine anesthesia is 0.6 mg/ kg, which results
in adequate intubation conditions within 60 seconds in nearly all patients.
The recommended rocuronium intubating dose during RSI anesthesia is 1.0-1.2 mg/kg, after
which optimum tracheal intubation conditions are also achieved within 60 seconds in nearly
all patients. If the standard dose of 0.6 mg/ kg is given on RSI of anesthesia, it is advised
to wait 90 seconds before attempting to intubate the trachea.
Nevertheless, this high dose has long duration of action and may pose a risk in patients with
unpredictable difficult intubation.
Dexmedetomidine (DEX), is a selective centrally acting α 2-adrenergic receptors agonist that
has been used successfully as procedural adjuvant, e.g., to minimize the stress response to
laryngoscopy during endotracheal intubation and has gained popularity in the peri-operative
period, due to its unique action as anxiolytic, sedative with no respiratory depression,
analgesic, opioid sparing effect, and Its ability to decrease overall anesthetic
requirements.
The aim of our study is to compare a combination of standard intubating dose of DEX and
rocuronium (0.6 mg /kg) to succinyl choline as regard endotracheal intubation condition
during RSI.
Material and method
Patients will be randomly allocated to one of two groups, of 120 each. The Dex pretreatment/
rocuronium group (DR group), and saline pretreatment/succinyl group (SS group). In the DR
group, patients shall receive pretreatment with Dex 1 µg / kg in 10 ml 0.9% saline over 10
minutes and rocuronium 0.6 mg/kg is the intubating muscle relaxant. In the SS group, patients
receive pretreatment with 10 ml 0.9% saline over 10 minutes, and succinyl choline 1mg/ kg is
the intubating muscle relaxant. Pretreatments will be given over 10 minutes using infusion
pump.
As soon as the pretreatment is completed, intravenous (IV) fentanyl 0.1 μg / kg and
preoxygenation for 3 minutes with a facemask, after which anesthesia is induced with IV
propofol 2 mg/ kg. Standardized intubating procedure is carried out that on loss of
consciousness, the neuromuscular relaxant drug is given per protocol, and 45 seconds later
the intubating anesthetist will be called in the operating room, at 50 seconds laryngoscopy
is introduced and at 60 seconds, the trachea would be expectedly successfully intubated. To
minimize interobserver bias, all intubations will be conducted by two designated senior
consultants. No ventilation will be carried out before orotracheal intubation. No cricoid
pressure shall be performed.
