Postoperative ComplicationsNCT04705948
Comparing the Effect of Ketamine and Magnesium Sulfate Gargling With Placebo on Post-operative Sore Throat
A study testing Magnesium sulfate versus ketamine in people with Postoperative Complications, run by University Tunis El Manar at 1 site in Tunisia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Magnesium sulfate versus ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTunisia
- Study dates
- 7 Oct 2020to 7 Feb 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effect of Ketamine and Magnesium Sulfate Gargling With Placebo on Post-operative Sore Throat: A Randomized Controlled Trial
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.
Read the 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)
- Conditions
- Postoperative Complications
- Being tested
- Magnesium sulfate versus ketamine
- Keywords
- sore throat, Ketamine, magnesium sulfate, endotracheal intubation
- Medical subject headings
- Postoperative Complications, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfate versus ketamineDrug
Also called postoperative complication
Magnesium sulfate versus ketamine for of post-operative sore throat after endotracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| ketamine group | Experimental | ketamine gargle (0.5 mg/kg up to 30 ml dextrose water) 15 minutes before the operation Receives: Drug: Magnesium sulfate versus ketamine |
| magnesium sulfate group | Experimental | magnesium sulfate gargle (20 mg/kg up to 30 mL G5%) 15 minutes before the operation. Receives: Drug: Magnesium sulfate versus ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of post-operative sore throat
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)
Measured: at the twenty-fourth hour postoperatively
Secondary outcomes (2)
Patient satisfaction
score of three points: satisfied (2 points); moderately satisfied (1 points); not satisfied (0 points)
Measured: at the twenty-fourth hour postoperatively
the incidence of cough
no cough 0 point and presence 1 point
Measured: at the twenty-fourth hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start7 Oct 2020
- Primary completion7 Feb 2021
- Study completion7 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mechaal Benali, University Tunis El Manar
- Investigators
- mechaal benali, PROFESSOR, Study director, university manar Tunis tunisia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705948
- Sponsor's protocol ID
- UTEM POST
- Status last verified
- May 2021
- First submitted
- 8 Jan 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of Ketamine and Magnesium Sulfate Gargling With Placebo on Post-operative Sore Throat: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04705948
- Acronym / sponsor ID
- UTEM POST
- Conditions
- Postoperative Complications
- Keywords
- sore throat, Ketamine, magnesium sulfate, endotracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 7 Feb 2021 (actual)
- Study completion
- 7 Feb 2021 (actual)
- First posted
- 12 Jan 2021 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine group | Experimental | Drug: Magnesium sulfate versus ketamineketamine gargle (0.5 mg/kg up to 30 ml dextrose water) 15 minutes before the operation |
| magnesium sulfate group | Experimental | Drug: Magnesium sulfate versus ketaminemagnesium sulfate gargle (20 mg/kg up to 30 mL G5%) 15 minutes before the operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Magnesium sulfate versus ketamineAlso: postoperative complicationMagnesium sulfate versus ketamine for of post-operative sore throat after endotracheal intubation | Drug | ketamine group, magnesium sulfate group |
Primary outcome
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)
2 secondary outcomes
Patient satisfaction
Time frame: at the twenty-fourth hour postoperatively
the incidence of cough
Time frame: at the twenty-fourth hour postoperatively
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 11 May 2021.
- 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.
mechaal benali, PROFESSOR study director
university manar Tunis tunisia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium sulfate versus ketamine in people with Postoperative Complications, run by University Tunis El Manar at 1 site in Tunisia.
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 3 inclusion and 7 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 11 May 2021. 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 Tunisia. 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.
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?
severity of post-operative sore throat (time frame: at the twenty-fourth hour postoperatively). 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 11 May 2021; AzTrials last refreshed its copy on 7 Nov 2026.