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Comparing the Effect of Ketamine and Magnesium Sulfate Gargling With Placebo on Post-operative Sore Throat

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ClinicalTrials.gov Identifier: NCT04705948
Recruitment Status : Recruiting
First Posted : January 12, 2021
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Mechaal Benali, University Tunis El Manar

Tracking Information
First Submitted Date  ICMJE January 8, 2021
First Posted Date  ICMJE January 12, 2021
Last Update Posted Date January 12, 2021
Actual Study Start Date  ICMJE October 7, 2020
Estimated Primary Completion Date February 7, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2021)
severity of post-operative sore throat [ Time Frame: at the twenty-fourth hour postoperatively ]
The severity of POST was scored on a three-point score from 0 to 2 (0 = No pain; 1 = Oropharyngeal pain on speaking; 2 = Spontaneous oropharyngeal pain)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2021)
  • Patient satisfaction [ Time Frame: at the twenty-fourth hour postoperatively ]
    score of three points: satisfied (2 points); moderately satisfied (1 points); not satisfied (0 points)
  • the incidence of cough [ Time Frame: at the twenty-fourth hour postoperatively ]
    no cough 0 point and presence 1 point
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing the Effect of Ketamine and Magnesium Sulfate Gargling With Placebo on Post-operative Sore Throat
Official Title  ICMJE Comparing the Effect of Ketamine and Magnesium Sulfate Gargling With Placebo on Post-operative Sore Throat: A Randomized Controlled Trial
Brief Summary

A prospective randomized double-blind study including patients ASA I-II, aged more than 18 years undergoing surgery under general anesthesia (GA) and endotracheal intubation. Patients were randomized allocated into 2 groups: ketamine group received ketamine gargle (0.5 mg/kg up to 30 ml dextrose water) and magnesium group received magnesium sulfate gargle (20 mg/kg up to 30 mL dextrose water ) 15 minutes before the operation.

Our primary outcome is sore throat and the secondary judging criteria are cough, dysphonia and satisfaction. A standardized anesthesia protocol was followed for all patients. After extubation, the patients were asked to grade POST, hoarseness, and cough at 15 min, 1h, and 24 h.

Detailed Description

This is a prospective, single-center, randomized, double-blind study. the investigators included in the study the patients:

whose age is greater than or equal to 18 years; ASA class 1 or 2, proposed for elective visceral, orthopedic, oncology, ophthalmologic, urologic surgery under general anesthesia with orothracheal intubation, expected duration ≤ 120 min.

the non-inclusion criteria are known allergy to ketamine or maguisuim sulphate, ASA 3 and more, cervical surgery; rapid sequence induction, difficult intubation planned or history of difficult intubation, malformation of the O.R.L sphere; upper respiratory tract infections. the need for multiple laryngoscopies for orotracheal intubation (≥ 2 attempts); the need for a postoperative nasogastric tube.

randomization is performed upon entering the operating room. The gargle allocation scheme, Ketamine Group or Magnesium Sulfate Group was randomly generated using a randomization table with an allocation ratio of 1: 1.

Postoperative follow-up was carried out in the post-intervention monitoring room then in hospitalization within the various referring services (general surgery, orthopedics, O.R.L and ophthalmology).

On the day of the procedure, the doctor responsible for the study prepares the two types of solutions containing:

  • One of magnesium sulfate (20mg / kg diluted in 30cc of 5% glucose serum);
  • The other ketamine (50mg diluted in 30cc of 5% glucose serum). These two solutions were distributed over two groups of patients for use as a gargle, lasting at least 60 seconds for each patient in each group and 15 minutes before the surgery.

The primary endpoint is the incidence and severity of POST at the twenty-fourth hour postoperatively The secondary outcomes are the incidence and severity of POST at 15 minutes and one hour postoperatively; The occurrence of cough, The presence of dysphonia and Patient satisfaction

The severity of POST was scored on a three-point score from 0 to 2 (0 = No pain; 1 = Oropharyngeal pain on speaking; 2 = Spontaneous oropharyngeal pain)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Complications
Intervention  ICMJE Drug: Magnesium sulfate versus ketamine
Magnesium sulfate versus ketamine for of post-operative sore throat after endotracheal intubation
Other Name: postoperative complication
Study Arms  ICMJE
  • Experimental: ketamine group
    ketamine gargle (0.5 mg/kg up to 30 ml dextrose water) 15 minutes before the operation
    Intervention: Drug: Magnesium sulfate versus ketamine
  • Experimental: magnesium sulfate group
    magnesium sulfate gargle (20 mg/kg up to 30 mL G5%) 15 minutes before the operation.
    Intervention: Drug: Magnesium sulfate versus ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 8, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 7, 2021
Estimated Primary Completion Date February 7, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • whose age is greater than or equal to 18 years; ASA class 1 or 2, proposed for elective visceral, orthopedic, oncology, ophthalmologic, urologic surgery under general anesthesia with orothracheal intubation, expected duration ≤ 120 min.

Exclusion Criteria:

  • the non-inclusion criteria are known allergy to ketamine or maguisuim sulphate, ASA 3 and more, cervical surgery; rapid sequence induction, difficult intubation planned or history of difficult intubation, malformation of the O.R.L sphere; upper respiratory tract infections. the need for multiple laryngoscopies for orotracheal intubation (≥ 2 attempts); the need for a postoperative nasogastric tube.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: mechaal benali, PROFESSOR +21698657034 ext 00216 mechaal_benali@yahoo.fr
Contact: BECEM TRABELSI, ast prof 0021672100500 ext 00216 trabelsi.becem@gmail.com
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04705948
Other Study ID Numbers  ICMJE UTEM POST
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mechaal Benali, University Tunis El Manar
Study Sponsor  ICMJE University Tunis El Manar
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: mechaal benali, PROFESSOR university manar Tunis tunisia
PRS Account University Tunis El Manar
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP