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NCT Number: NCT04705948

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mechaal Benali

Nabeul, Mrezga Hammamet, 8000, Tunisia

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age is greater than or equal to 18 years
  • ASA class 1 or 2
  • patients proposed for elective visceral, orthopedic, oncology, ophthalmologic, urologic surgery under general anesthesia with orothracheal intubation

Exclusion criteria

  • known allergy to ketamine or maguisuim sulphate
  • ASA 3 and more
  • cervical surgery
  • difficult intubation planned or history of difficult intubation
  • malformation of the O.R.L sphere
  • the need for multiple laryngoscopies for orotracheal intubation (≥ 2 attempts);
  • the need for a postoperative nasogastric tube.

Treatment and study plan

Magnesium sulfate versus ketamine

Drug

Magnesium sulfate versus ketamine for of post-operative sore throat after endotracheal intubation

Other names: postoperative complication

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. the incidence of cough

    Time frame: at the twenty-fourth hour postoperatively

    no cough 0 point and presence 1 point

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

Comparing the Effect of Ketamine and Magnesium Sulfate Gargling With Placebo on Post-operative Sore Throat: A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 12, 2021
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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