Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05421962 |
| Other study ID # |
KMA |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
December 15, 2021 |
Study information
| Verified date |
June 2022 |
| Source |
Cantonal Hospital Zenica |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Aim: The aim of the study was to to compare the analgesic effects of ketamine over fentanyl
combined with propofol in analgesia-based elective colonoscopy with purpose of patient safety
and satisfaction.
Methods: This is a double-blinded prospective randomized controlled trial. Ninety patients
were included and randomized to either fentanyl-propofol (Group FP, n: 30), ketamine-propofol
(Group KP, n: 30) or propofol-control group (Group C, n: 30). Group FP patients received
fentanyl and propofol, Group KP received ketamine and propofol and Group C, propofol. In all
groups, incremental doses of propofol were used to maintain a Ramsay sedation score (RSS) of
5. Respiratory depression, hemodynamic parameters were monitored for the first minute and
every 5 minutes during endoscopy. Fifteen minutes after the procedure, the degree of pain was
assessed using a visual analog scale (VAS), the quality of recovery according to the Aldrete
score (ARS), complications during and after the procedure and additional doses of propofol
were recorded.
Description:
This prospective, randomized control study was conducted after obtaining the approval of the
Ethics Committee and the written consent of the patients, in the Department of Anesthesia and
Intensive care unit between 2020 and 2021. Ninety ASA physical statuses I and II, patients
who were older than 18 years were included in this study. Exclusion criteria were: all
colonoscopies lasting longer than 30 minutes, patients with previous abdominal surgery,
patients treated for neuropathic pain, malignant and respiratory diseases, pregnant women,
gastrointestinal obstruction, patients using antihypertensive and antiarrhythmic drugs,
psychiatric patients, patients with ASA physical status III and higher, and patients who
refused to participate in the study.
All patients had fasted for the previous 8 hours prior to the procedure and had undergone a
digestive tract preparation procedure. Patients were randomly (computer generated) divided
into three groups: patients whom were administrated fentanyl and propofol (Group FP),
patients whom were administrated ketamine and propofol (Group KP) and patients whom were
administrated propofol (Group C-control group). The syringes were coded before the procedure
by an anesthetist who was not involved in the sedation process. Syringes were also selected
in terms of volume in a similar manner, while patients, anesthesiologists, colonoscopists,
and anesthetists were blinded to the medication regimen.
After the patient admission to the endoscopy room and identification, an intravenous line was
placed and intravenous fluid administration (saline) was started. All patients were placed in
the lateral position and placed on non-invasive blood pressure monitoring, three-channel ECG
and peripheral oxygen saturation. Oxygen support is provided via a facial mask at a flow rate
of 5 L/min.
Sedation protocol. All three groups of patients were premedicated with 0.05 mg kg-1 of
midazolam (PanPharma), 5 minutes before the starting of the procedure. Afterwards, sedation
induction was performed with 1 mcg kg-1 of fentanyl (Panpharma; SanMed) and 0.5 mg kg-1 of
propofol (Fresenius Kabi; Amicus Pharma) for Group FP. Ketamine (Inresa Arzneimittel) 0.5 mg
kg-1 and 0.5 mg kg-1 of propofol for Group KP, and 1 mg kg-1 of propofol for Group C. During
the procedure, the patients RSS scores was maintained at 5 with an additional 0.5 mg kg-1
bolus dose of propofol when required.
Data collection and measurements Assessment of hemodynamic and respiratory stability. MAP and
HR were noted upon entry of the patient into the endoscopic cabinet, immediately after the
administration of propofol, and then every 5 minutes during the procedure. A number of
episodes of hypertension, hypotension, tachycardia, and bradycardia were noted. Hypertension
is defined as an increase in blood pressure greater than 20%, and hypotension for a decrease
in blood pressure greater than 20% from baseline. Tachycardia is defined as an increase in
heart rate> 100 beats per minute. Bradycardia as a drop in heart rate <50 beats per minute.
Respiratory stability was assessed at the same time intervals using a peripheral pulse
oximeter. A number of desaturation episodes were recorded for each group. Desaturation was
defined as a decrease in peripheral oxygen saturation <95% measured with a pulse oximeter.
Assessment of sedation level. The degree of sedation were assessed by RSS, immediately after
propofol administration and every 5 minutes during the procedure. RSS is a subjective method
of sedation assessment, where patient sedation levels are divided into 6 groups (1. anxious,
agitated or anxious or both; 2. cooperative, oriented and calm; 3. calm, responds only to
command; 4. quick response to audible stimulus or light tapping on the forehead; 5. slow
response to sound stimulus or light tapping on the forehead; 6. no response to stimulus). A
number of additional bolus doses were recorded for each group.
Assessment of postprocedural abdominal pain. The patient's subjective feeling of
post-procedural pain were determined by a 10 cm VAS. The scale is horizontal, ungraded,
bounded at both ends by vertical lines that define the extreme limits of the indicators being
measured. The experienced pain sensation were marked by the patient on a scale, and then the
marked position were assigned a numerical value according to the VAS score as follows: VAS
score: no pain 0-10 mm; mild pain 10-30 mm; moderate pain 30-70 mm; severe pain 70-100 mm.
Assessment of postprocedural pain were performed 15 minutes after the procedure.
Recovery quality assessment. The quality of the patient's recovery were assessed by ARS 15
minutes after the end of the procedure. Using ARS we examined the following five criteria:
motor activity (possibility of moving 2 extremities/all extremities, no movement of
extremities on command), breathing (deep breathing with cough reflex, hypoventilation,
apnea), blood pressure (+20 mmHg, + 20-50 mmHg, +50 mmHg relative to baseline), consciousness
(awake, awake on call, unresponsive) and skin color (pink, pale, cyanotic). With ARS, each
criterion is evaluated separately from 0 to 2, with a maximum score of 10. A score with a
range of 8 and 9 is considered satisfactory.
Estimation of complication frequency. The frequency of procedural complications was
monitored: hallucinations, confusion, unpleasant dreams, anxiety, weakness, vomiting and
nausea. Hallucinations were defined as a visual or auditory sensory event that occurs without
appropriate objective sensory stimulation. Confusion were defined as an inability to think
clearly, an expression of a disorder of consciousness, and unpleasant dreams as an unpleasant
mental activity during sleep. Anxiety were defined as a feeling of general tension, anxiety,
great stress, panic or fear, and weakness as a feeling of loss of muscle strength, general
fatigue or functional limitation. Vomiting were defined as a reflex act, during which the
contents of the stomach or the initial part of the small intestine return through the mouth
and are expelled into the external environment. Nausea were defined as a feeling of
discomfort in the upper part of the digestive system with a feeling of threatening vomiting.
Patients were interviewed to mark the experienced feeling with YES or NO.
