Sore ThroatPhase 3NCT03729973
Comparing Efficacy Preoperative Nebulized: Ketamine , Mgspo4 ,and Lidocaine In Attenuating Endotracheal Sore Throat
A Phase 3 study testing Ketamine, Magnesium Sulfate and Lidocaine in people with Sore Throat, run by Zagazig University at 1 site in Egypt.
Trial summary
One of the most common complications after endotracheal intubation is sore throat Lidocaine jelly or spray, preoperative gargles with licorice or ketamine or I.V steroids used for prophylaxis against POST are expensive ,and having much more side effects,but nebulized lidocaine is easily found with decreasing cost… Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sore Throat
- What is being tested?
- Ketamine, Magnesium Sulfate and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2018to 1 Mar 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient acceptance.
- Age (21-45) years old.
- American Society of Anesthesiologists (ASA) I / II
- elective surgery of approximately 2-3h duration needing endotracheal intubation
- Patient With BMI(Body Mass Index)(25-30)
Who cannot join
- Patient refusal.
- Altered mental status.
- History of allergy to drugs in the study
- .Patients with history of pervious sore throat
- using steroids or NSAIDs,with asthma
- neuromuscular disease
Show all 9Show fewer
- , Mallampati grade>2, with >2 attempts of intubations,
- underlying neck ,and laparoscopic surgeries,
- pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing The Efficacy Of Preoperative Nebulized: Ketamine, Magnesium Sulfate, and Lidocaine In Attenuating Postoperative Sore Throat After Endotracheal Intubation
One of the most common complications after endotracheal intubation is sore throat Lidocaine jelly or spray, preoperative gargles with licorice or ketamine or I.V steroids used for prophylaxis against POST are expensive ,and having much more side effects,but nebulized lidocaine is easily found with decreasing cost ,easily administered ,acts immediately with short duration ,minimal side effects ,and no term residual side effects.
Nebulized ketamine was found to have a protective effect on allergen-induced airway inflammatory injury , high airway reactivity ,and decreasing postoperative sore throat (POST) incidence .
Magnesium sulfate is similar to ketamine in blocking the N-methyl-D-aspartate receptors.
Read the detailed description
Patients and Methods a) Sample size:Assuming that mean+standard Deviation of age of nebulized ketamine group is 42.3+11.9 and normal saline group is 35.5+11.7 .So sample size is calculated by open source Epidemiologic statistics for public health (openEpi) to be 100 cases in 4 groups (25 cases in each group) with confidence level 95% and power of test is 80%.
All Cases Will Undergo:
- Patient Examination: All participating patients will be interviewed preoperatively during their preoperative preparation. The goal and endpoints of the study will be discussed. and written informed consent will be included in the study.
On physical examination, special attention will be given to document vital signs, cardiac, chest condition and exclude exclusion criteria , laboratory investigations will be reviewed ..
In preparation room an I.V line was secured ,and stranded monitoring was connected to patient.
Patients nebulized by compressor nebulizing for 15 minutes. Patient was then transferred to operating room where a stranded monitor was connected (Non-invasive blood pressure, pulse oximeter, ECG,and capnography).
Patient was pre-oxygenated with 5 Litter/min (L/min) O2, 100% for 3-5 min. premedication with glycopyrrolate 0.01 milgram/kilogram (mg/kg), midazolam 0.02mg/kg.
Induction was done by fentanyl 2ug/kg, propofol 2mg/kg, endotracheal intubation was facilitated by atracurium 0.6mg/kg, and intubation by soft seal cuffed sterile polyvinyl chlorid tracheal tube of 7mm inner diameter in female ,and 8mm in male patients, the cuff was inflated with air.All intubation was performed by an experienced anaesthesiologist.
Maintenance of anaesthesia done using isoflurane 1 Minimum Alveolar Concentration (MAC) ,and atracurium. The last dose of atracurium was given 20 min. before extubation.
At the end of the surgery, the inhalational anaesthetic was turned off, and the muscle relaxant was reversed by a combination of neostigmine 0.05mg/kg, and glycopyrrolate 0.01mg/kg.The patient was extubated after extubation criteria were met, and the patient was transferred to recovery room.
In the recovery room, all patients received O2 2.5L/min by face mask.The presence of sore throat was noted at rest and on swallowing immediately after extubation.
The intensity of sore throat was recorded at 2,4,8,12,24 hours postoperatively. In postoperative ward, patients were also monitored haemodynamics (BLp, O2 saturation, pulse), drug related side effects,and sedation level using A=Alert, V=Verbal, P=Painful,U=Unresponsive ( AVPU)score .
Sore throat was measured on 4 point scale (0-3). 0= no sore throat
- mild sore throat (complaint of sore throat on asking).
- moderate sore throat (change in voice or hoarseness associated with throat pain).
- sever sore throat (change in voice or hoarseness associated with throat pain). Protocol for pain management, I.V diclofenac 75mg every 12h. Patient with sore throat score = 2 or 3 will be treated with IV diclofenac 1mg/kg every 8h.
Patient satisfaction:The patients will be asked to rate the overall degree of satisfaction of the analgesia using a 1-3 verbal scale (1 = unsatisfactory analgesia, 2 = satisfactory analgesia, and 3 = excellent analgesia) .
VII- Side effects and Complications as: Nausea, Vomiting, Local anaesthetics toxicity or other complications will be documented.
- Conditions
- Sore Throat
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called (Ketalar, 50 Mg/mL Injectable Solution)
Patients nebulized ketamine by compressor nebulizing for 15 minutes.
Magnesium SulfateDrug
Also called (Magnesium Sulfate 500 /ML)
Patients nebulized magnesium sulfate 250mg (3ml)plus 2ml normal saline by compressor nebulizing for 15 minutes.
LidocaineDrug
Also called (Xylocaine 2 % Injectable Solution)
In preparation room an I.V line was secured ,and standard monitoring was connected to patient.
Patients nebulized lidocaine 5ml by compressor nebulizing for 15 minutes.
Normal salineDrug
Also called (Normal Saline 0.9% Infusion Solution)
In preparation room an I.V line was secured ,and standard monitoring was connected to patient.
Patients nebulized by compressor nebulizing 5ml normal saline for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Group (K) | Active comparator | Group (K) (n=25): patients nebulized ketamine 50 mg(milgram) (1ml) plus 4ml normal saline.So total volume (5ml).
In preparation room an I.V line was secured ,and stranded monitoring was connected to patient.
Patients nebulized 1ml ketamine (Ketalar 50mg/VI Solution for Injection) by compressor nebulizing for 15 minutes. Receives: Drug: Ketamine |
| Group (M) | Active comparator | Group M(n=25) : patients nebulized isotonic magnesium sulfate 250mg (3ml)( 50% Magnesium Sulfate Injection)plus 1ml normal saline.
In preparation room an I.V line was secured ,and stranded monitoring was connected to patient.
Patients nebulized by compressor nebulizing for 15 minutes. Receives: Drug: Magnesium Sulfate |
| Group (L) | Active comparator | Group (L) (n=25): patients nebulized lidocaine 2% 100mg .So total volume (5ml). In preparation room an I.V line was secured ,and stranded monitoring was connected to patient.
Patients nebulized by compressor nebulizing for 15 minutes. Receives: Drug: Lidocaine |
| Group (C) | Active comparator | Group (C) (n=25): patients nebulized normal saline(0.9%). 5ml .In preparation room an I.V line was secured ,and stranded monitoring was connected to patient.
Patients nebulized by compressor nebulizing for 15 minutes. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
4 point sore throat intensity: self reported sore throat intensity at 2,4,8,12,24 hours postoperatively. .
The intensity of sore throat will be recorded at 2,4,8,12,24 hours postoperatively on 4 point scale (0-3):
0= no sore throat
- mild sore throat (complaint of sore throat on asking).
- moderate sore throat (change in voice or hoarseness associated with throat pain).
- sever sore throat (change in voice or hoarseness associated with throat pain).
Measured: 2,4,8,12,24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start15 Nov 2018
- Primary completion1 Jan 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore ThroatStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alshaimaa Abdel Fattah Kamel, Zagazig University
- Investigators
- Alshaimaa Kamel, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729973
- Sponsor's protocol ID
- 4915
- Status last verified
- Mar 2019
- First submitted
- 27 Oct 2018
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing The Efficacy Of Preoperative Nebulized: Ketamine, Magnesium Sulfate, and Lidocaine In Attenuating Postoperative Sore Throat After Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT03729973
- Acronym / sponsor ID
- 4915
- Conditions
- Sore Throat
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the most common complications after endotracheal intubation is sore throat Lidocaine jelly or spray, preoperative gargles with licorice or ketamine or I.V steroids used for prophylaxis against POST are expensive ,and having much more side effects,but nebulized lidocaine is easily found with decreasing cost ,easily administered ,acts immediately with short duration ,minimal side effects ,and no term residual side effects.
Nebulized ketamine was found to have a protective effect on allergen-induced airway inflammatory injury , high airway reactivity ,and decreasing postoperative sore throat (POST) incidence .
Magnesium sulfate is similar to ketamine in blocking the N-methyl-D-aspartate receptors.
Detailed description
Patients and Methods a) Sample size:Assuming that mean+standard Deviation of age of nebulized ketamine group is 42.3+11.9 and normal saline group is 35.5+11.7 .So sample size is calculated by open source Epidemiologic statistics for public health (openEpi) to be 100 cases in 4 groups (25 cases in each group) with confidence level 95% and power of test is 80%.
All Cases Will Undergo:
- Patient Examination: All participating patients will be interviewed preoperatively during their preoperative preparation. The goal and endpoints of the study will be discussed. and written informed consent will be included in the study.
On physical examination, special attention will be given to document vital signs, cardiac, chest condition and exclude exclusion criteria , laboratory investigations will be reviewed ..
In preparation room an I.V line was secured ,and stranded monitoring was connected to patient.
Patients nebulized by compressor nebulizing for 15 minutes. Patient was then transferred to operating room where a stranded monitor was connected (Non-invasive blood pressure, pulse oximeter, ECG,and capnography).
Patient was pre-oxygenated with 5 Litter/min (L/min) O2, 100% for 3-5 min. premedication with glycopyrrolate 0.01 milgram/kilogram (mg/kg), midazolam 0.02mg/kg.
Induction was done by fentanyl 2ug/kg, propofol 2mg/kg, endotracheal intubation was facilitated by atracurium 0.6mg/kg, and intubation by soft seal cuffed sterile polyvinyl chlorid tracheal tube of 7mm inner diameter in female ,and 8mm in male patients, the cuff was inflated with air.All intubation was performed by an experienced anaesthesiologist.
Maintenance of anaesthesia done using isoflurane 1 Minimum Alveolar Concentration (MAC) ,and atracurium. The last dose of atracurium was given 20 min. before extubation.
At the end of the surgery, the inhalational anaesthetic was turned off, and the muscle relaxant was reversed by a combination of neostigmine 0.05mg/kg, and glycopyrrolate 0.01mg/kg.The patient was extubated after extubation criteria were met, and the patient was transferred to recovery room.
In the recovery room, all patients received O2 2.5L/min by face mask.The presence of sore throat was noted at rest and on swallowing immediately after extubation.
The intensity of sore throat was recorded at 2,4,8,12,24 hours postoperatively. In postoperative ward, patients were also monitored haemodynamics (BLp, O2 saturation, pulse), drug related side effects,and sedation level using A=Alert, V=Verbal, P=Painful,U=Unresponsive ( AVPU)score .
Sore throat was measured on 4 point scale (0-3). 0= no sore throat
- mild sore throat (complaint of sore throat on asking).
- moderate sore throat (change in voice or hoarseness associated with throat pain).
- sever sore throat (change in voice or hoarseness associated with throat pain). Protocol for pain management, I.V diclofenac 75mg every 12h. Patient with sore throat score = 2 or 3 will be treated with IV diclofenac 1mg/kg every 8h.
Patient satisfaction:The patients will be asked to rate the overall degree of satisfaction of the analgesia using a 1-3 verbal scale (1 = unsatisfactory analgesia, 2 = satisfactory analgesia, and 3 = excellent analgesia) .
VII- Side effects and Complications as: Nausea, Vomiting, Local anaesthetics toxicity or other complications will be documented.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group (K) | Active comparator | Drug: KetamineGroup (K) (n=25): patients nebulized ketamine 50 mg(milgram) (1ml) plus 4ml normal saline.So total volume (5ml). In preparation room an I.V line was secured ,and stranded monitoring was connected to patient. Patients nebulized 1ml ketamine (Ketalar 50mg/VI Solution for Injection) by compressor nebulizing for 15 minutes. |
| Group (M) | Active comparator | Drug: Magnesium SulfateGroup M(n=25) : patients nebulized isotonic magnesium sulfate 250mg (3ml)( 50% Magnesium Sulfate Injection)plus 1ml normal saline. In preparation room an I.V line was secured ,and stranded monitoring was connected to patient. Patients nebulized by compressor nebulizing for 15 minutes. |
| Group (L) | Active comparator | Drug: LidocaineGroup (L) (n=25): patients nebulized lidocaine 2% 100mg .So total volume (5ml). In preparation room an I.V line was secured ,and stranded monitoring was connected to patient. Patients nebulized by compressor nebulizing for 15 minutes. |
| Group (C) | Active comparator | Drug: Normal salineGroup (C) (n=25): patients nebulized normal saline(0.9%). 5ml .In preparation room an I.V line was secured ,and stranded monitoring was connected to patient. Patients nebulized by compressor nebulizing for 15 minutes. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient acceptance.
- Age (21-45) years old.
- American Society of Anesthesiologists (ASA) I / II
- elective surgery of approximately 2-3h duration needing endotracheal intubation
- Patient With BMI(Body Mass Index)(25-30)
Key exclusion criteria (9 listed)
- Patient refusal.
- Altered mental status.
- History of allergy to drugs in the study
- .Patients with history of pervious sore throat
- using steroids or NSAIDs,with asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineAlso: (Ketalar, 50 Mg/mL Injectable Solution)Patients nebulized ketamine by compressor nebulizing for 15 minutes. | Drug | Group (K) |
| Magnesium SulfateAlso: (Magnesium Sulfate 500 /ML)Patients nebulized magnesium sulfate 250mg (3ml)plus 2ml normal saline by compressor nebulizing for 15 minutes. | Drug | Group (M) |
| LidocaineAlso: (Xylocaine 2 % Injectable Solution)In preparation room an I.V line was secured ,and standard monitoring was connected to patient. Patients nebulized lidocaine 5ml by compressor nebulizing for 15 minutes. | Drug | Group (L) |
| Normal salineAlso: (Normal Saline 0.9% Infusion Solution)In preparation room an I.V line was secured ,and standard monitoring was connected to patient. Patients nebulized by compressor nebulizing 5ml normal saline for 15 minutes. | Drug | Group (C) |
Primary outcome
4 point sore throat intensity: self reported sore throat intensity at 2,4,8,12,24 hours postoperatively. .
Time frame: 2,4,8,12,24 hours
The intensity of sore throat will be recorded at 2,4,8,12,24 hours postoperatively on 4 point scale (0-3): 0= no sore throat 1. mild sore throat (complaint of sore throat on asking). 2. moderate sore throat (change in voice or hoarseness associated with throat pain). 3. sever sore throat (change in voice or hoarseness associated with throat pain).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alshaimaa Kamel, MD principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine, Magnesium Sulfate and Lidocaine in people with Sore Throat, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4 point sore throat intensity: self reported sore throat intensity at 2,4,8,12,24 hours postoperatively. . (time frame: 2,4,8,12,24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.