Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04293081 |
| Other study ID # |
FMASU R 01/2019 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 16, 2019 |
| Est. completion date |
July 30, 2019 |
Study information
| Verified date |
August 2020 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of the study is to identify the role of preoperative chlorepheniramine maleate on
alleviating or reducing the severity of postoperative agitation following FESS procedures.
Description:
A total of 90 adult patients undergoing FESS procedure for sinusitis with postoperative nasal
packing. Written informed consent will be obtained from all patients before randomization.
Patients will be divided equally into two groups the first 45 patients will be assigned to
chlorepheniramine maleate group (A) and the other group to placebo group (B). Group
assignment, preparation and administration of drugs will be performed by a junior anesthetist
who is neither involved nor interested by any means in the study. Blind grouping will be kept
to all including the patients themselves, until the completion of study.
Inclusion and Exclusion Criteria The inclusion criteria of these patients include adult
patients (age 18- 60 years), class I-II according to American society of anaesthesiologists
(ASA) physical status subjected to FESS without septoplasty. Exclusion criteria include;
patients below 18 years old or over 60 years old, patients with ASA physical status class
III-IV, morbid obesity with BMI > 30 kgm-2 at initial hospital visit, history of
neuro-psychatric ailment or chronic use of antipsychotic drugs, severe cardiovascular
disease, any coagulopathies, pregnancy, history of relevant drug allergy, any possibility of
anticipated difficult intubation.
Preoperative Anesthetic Assessment All patients will be subjected to a thorough medical
history, physical examination, laboratory investigations (fasting blood sugar, kidney, liver
function tests, serum electrolytes, coagulation profile, and electrocardiogram)
preoperatively. They will be also counseled about the anesthetic management and potential
complications of both surgery and anesthesia, and the explanations of numerical pain analogue
scale (NAS) from 0-10. All these data will be documented. A thorough airway assessment by
Mallampati classification, mouth opening, neck movement, thyromental distance will be done to
find out any possibility of difficult intubation. If there is a chance of significant
difficult intubation, the patient will be excluded from the study.
Anesthetic Protocol All patients admitted to OR induction area where patient identification
is confirmed and an 18-gauge intravenous cannula will be inserted to all Participants.
Participants of group A will receive only one ampoule of 45.5 mg/ 2mL chlorepheniramine
maleate diluted in 8 ml isotonic saline intravenous (I.V) prior to induction of general
anesthesia by 30 minutes while participants in group (B) will receive 10 ml isotonic saline
(placebo) by the same route as control.
General anesthesia will be started for all patients with intravenous lignocaine 1.0 mg/kg,
propofol 2.0 mg/kg, then atracurium 0.5 mg/kg, fentanyl 1 µg/kg then they will be intubated
orally which is fixed after confirmation of its place by auscultation then oral packing with
wet gauze under vision using laryngoscope. Anesthesia will be maintained by mixture of O2 and
air along with 2% sevoflurane then atracurium 0.1 mg/kg will be given for maintenance of
muscle relaxation.. All patients will be monitored by standard monitors including, the pulse
oximeter, non-invasive blood pressure, end-tidal C02, and electrocardiogram. Moreover,
bispectral index monitor is used to assess depth of general anesthesia.
Deliberate hypotension will be done using intravenous infusion of nitroglycerine at a rate of
5 to 20 µg/ kg /minute titrated to target mean arterial blood pressure (Mbp) of 55±5 mmHg.
Hypotensive anesthesia will be maintained throughout the surgical procedure. At the end of
surgery, mean arterial blood pressure (Mbp) will be elevated by stoppage of nitroglycerine
infusion and infusing crystalloids (500-1000ml) together with administration of ephedrine
hydrochloride 10 mg IV to restore the mean arterial blood pressure back to the preoperative
value. Upon attaining spontaneous breathing muscle relaxant will be antagonized by 50 µg/kg
neostigmine and 10 µg/kg glycopyrolate, then oral pack will be removed under vision with
thorough oral suctioning then awake extubation will be done and the patients will be
transferred to the recovery unit.
Postoperative Analgesic Regimen It will start immediately on arrival to the recovery unit
where patients received 16 mg lornoxicam slowly IV over 5 minutes. After that all patients
will receive acetaminophen 1 gm/6 h IV and 5 mg Nalbuphine IV if breakthrough pain develops
for the first day postoperative.
Patients Assessment Patients will be transferred to Post-anesthesia care unit PACU for
observation and assessment for agitation and pain. Upon arrival to PACU, a pulse oximeter and
Non invasive blood pressure (NIBP) monitors will be attached to the patient. Discharge
criteria from PACU will be stable vital signs, pain score less than or equal to 2, no nausea
or vomiting, calm and alert patient.
Assessment of agitation Postoperative agitation will be assessed in the PACU by a blinded
observer using the Richmond Agitation Sedation Scale (RASS) as follows: 0= Alert and calm +1=
Restless; Anxious and /or apprehensive but movements not aggressive. +2= agitated; Frequent
non-purposeful movement. +3= very agitated; Pulls on or removes the tubes or catheters or has
aggressive behavior toward staff. +4= combative; overly combative or violent. Total agitation
will be defined as the algebraic sum of agitation values will be observed at the measured
time points (0, 5, 10, 15, 30 minutes after recovery), and this will be used to correlate
agitation with other variables. The agitations score range will be from 0= no agitation to
20= severe persistent agitation.
In case of severe persistent agitation with RASS > 12 in the first 15 minutes postoperatively
patients will be reassured and midazolam 2 mg IV will be given to reduce agitation with
thorough follow up of patient's breathing.
Assessment of pain Pain intensity will be assessed as a secondary outcome to the
investigator's study using visual analogue scale where 0= no pain and 10 is the worst
imaginable pain as rated by the patient. A blinded team member assessed pain after evaluation
of last agitation point (30 minutes of recovery). Patient that exhibited no agitation will be
also evaluated for pain after 30 minutes of recovery. Nalbuphine will be used as rescue
analgesic to ameliorate pain. The use of nalbuphine after evaluation of agitation and
assessment of pain to avoid perplex to the outcome measurement. If pain is more than +6 on
VAS Nalbuphine will be given in 5 mg until pain score < 4. Pain assessment is done after 2, 6
, 12 and 24 hours postoperatively with calculating the frequency of rescue analgesia given
and the total dose of nalbuphine consumed during that time taking care not to exceed 5 Mg at
a time with drug lag of at least 2 hours between 2 successive doses of rescue agent.
The primary end point to this study is the occurance of severe agitation endangering the
patient, or the occurance hypoxemia, bleeding nasal or oral, or the occurance of
postoperative atypical hypotension.
