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Comparing Efficacy Preoperative Nebulized: Ketamine , Mgspo4 ,and Lidocaine In Attenuating Endotracheal Sore Throat

Primary Purpose

Sore Throat

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine
Magnesium Sulfate
Lidocaine
Normal saline
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sore Throat

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • , Mallampati grade>2, with >2 attempts of intubations,
  • underlying neck ,and laparoscopic surgeries,
  • pregnant women.

Sites / Locations

  • Zagazig University Hospitsals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group (K)

Group (M)

Group (L)

Group (C)

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
October 27, 2018
Last Updated
March 15, 2019
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT03729973
Brief Title
Comparing Efficacy Preoperative Nebulized: Ketamine , Mgspo4 ,and Lidocaine In Attenuating Endotracheal Sore Throat
Official Title
Comparing The Efficacy Of Preoperative Nebulized: Ketamine, Magnesium Sulfate, and Lidocaine In Attenuating Postoperative Sore Throat After Endotracheal Intubation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 ,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: a. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group (K)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group (M)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group (L)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group (C)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
(Ketalar, 50 Mg/mL Injectable Solution)
Intervention Description
Patients nebulized ketamine by compressor nebulizing for 15 minutes.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Other Intervention Name(s)
(Magnesium Sulfate 500 /ML)
Intervention Description
Patients nebulized magnesium sulfate 250mg (3ml)plus 2ml normal saline by compressor nebulizing for 15 minutes.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
(Xylocaine 2 % Injectable Solution)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
(Normal Saline 0.9% Infusion Solution)
Intervention Description
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.
Primary Outcome Measure Information:
Title
4 point sore throat intensity: self reported sore throat intensity at 2,4,8,12,24 hours postoperatively. .
Description
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).
Time Frame
2,4,8,12,24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 , Mallampati grade>2, with >2 attempts of intubations, underlying neck ,and laparoscopic surgeries, pregnant women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alshaimaa Kamel, MD
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig University Hospitsals
City
Zagazig
ZIP/Postal Code
055
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparing Efficacy Preoperative Nebulized: Ketamine , Mgspo4 ,and Lidocaine In Attenuating Endotracheal Sore Throat

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