"The effect of Betamethasone gel and NSAID gel lubricated on the laryngeal mask on pain in the throat, hoarseness and cough after anesthesia. "

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002009-37-DK

Enrollment

Registered

2017-05-17

Start date

2017-07-14

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

'Healthy volunteers' (sore throat, hoarseness and cough, consumption of analgesics, postoperative itching, numbness and burning sensation from the throat) MedDRA version: 20.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Ipren gel 50 mg/g. Pharmaceutical Form: Gel INN or Proposed INN: IBUPROFEN Other descriptive name: Ipren Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients who understand and speak Danish • The patient set for eye surgery in general anesthesia with FLMA as airway management. • Age =18 years • ASA 1-3. • BMI =18 and =40 • Patients without cognitive disorders that may prevent relevant responses in the study. • Patients without upper respiratory tract infection. • Patients who are not in steroid treatment before surgery. • Patients who do not have an allergy to the substances used in the pilot study. (See side effects page 5) • Patients who have given their written informed consent to participate in the study after understanding the contents and limitations of the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Study participants who do not meet one or more of the inclusion criteria are not suitable for inclusion in this pilot study.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objektive of the Sub-study is to investigate the effect of Betamethason gel and NSAID gel lubricated on the Flexible laryngeal mask (FLMA) on the occurrence and strength of sore throat, hoarseness and cough in compared to a placebo group (Neutral Gel) and compared to each other. Our hypothesis is that Betamethasone Gel will be the most effective of the 2 active substances.;Secondary Objective: • The effect and difference between Betamethasone gel (Diprol 0.05%), NSAID gel (Ipren gel 0.5%) and placebo (Neutral gel) lubricated FLMA on the sore throat at 2, 4, 8 and 24 hours (T2, T4, T8, T24) after FLMA removal (T0). • The effect and difference between Betamethasone gel (Diprol 0.05%), NSAID gel (Ipren gel 0.5%) and placebo (Neutral gel) lubricated FLMA on hoarseness and cough at 2, 4, 6, 8 and 24 hours ( T2, T4, T6, T8, T24) after FLMA removal (T0). • The consumption of analgesics at 2, 4, 6, 8 and 24 hours (T2, T4, T6, T8, T24) after FLMA removal (T0). • The occurrence of postoperative itching, numbness and burning sensation from the neck at 2, 4, 6, 8 and 24 hours (T2, T4, T6, T8, T24) after FLMA removal (T0).;Primary end point(s): The effect and difference between Betamethasone gel (Diprol 0.05%), NSAID gel (Ipren gel 0.5%) and placebo (Neutral gel) lubricated FLMA on the sore throat at time 6 hours (T6) after FLMA removal (T0).;Timepoint(s) of evaluation of this end point: 6 hours (T6) after FLMA removal (T0).	—

Measure

Time frame

Main Objective: The main objektive of the Sub-study is to investigate the effect of Betamethason gel and NSAID gel lubricated on the Flexible laryngeal mask (FLMA) on the occurrence and strength of sore throat, hoarseness and cough in compared to a placebo group (Neutral Gel) and compared to each other. Our hypothesis is that Betamethasone Gel will be the most effective of the 2 active substances.;Secondary Objective: • The effect and difference between Betamethasone gel (Diprol 0.05%), NSAID gel (Ipren gel 0.5%) and placebo (Neutral gel) lubricated FLMA on the sore throat at 2, 4, 8 and 24 hours (T2, T4, T8, T24) after FLMA removal (T0). • The effect and difference between Betamethasone gel (Diprol 0.05%), NSAID gel (Ipren gel 0.5%) and placebo (Neutral gel) lubricated FLMA on hoarseness and cough at 2, 4, 6, 8 and 24 hours ( T2, T4, T6, T8, T24) after FLMA removal (T0). • The consumption of analgesics at 2, 4, 6, 8 and 24 hours (T2, T4, T6, T8, T24) after FLMA removal (T0). • The occurrence of postoperative itching, numbness and burning sensation from the neck at 2, 4, 6, 8 and 24 hours (T2, T4, T6, T8, T24) after FLMA removal (T0).;Primary end point(s): The effect and difference between Betamethasone gel (Diprol 0.05%), NSAID gel (Ipren gel 0.5%) and placebo (Neutral gel) lubricated FLMA on the sore throat at time 6 hours (T6) after FLMA removal (T0).;Timepoint(s) of evaluation of this end point: 6 hours (T6) after FLMA removal (T0).

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Secondary

Measure	Time frame
Secondary end point(s): • The effect and difference between Betamethasone gel (Diprol 0.05%), NSAID gel (Ipren gel 0.5%) and placebo (Neutral gel) lubricated FLMA on the sore throat at 2, 4, 8 and 24 hours (T2, T4, T8, T24) after FLMA removal (T0). • The effect and difference between Betamethasone gel (Diprol 0.05%), NSAID gel (Ipren gel 0.5%) and placebo (Neutral gel) lubricated FLMA on hoarseness and cough at 2, 4, 6, 8 and 24 hours ( T2, T4, T6, T8, T24) after FLMA removal (T0). • The consumption of analgesics at 2, 4, 6, 8 and 24 hours (T2, T4, T6, T8, T24) after FLMA removal (T0). • The occurrence of postoperative itching, numbness and burning sensation from the neck at 2, 4, 6, 8 and 24 hours (T2, T4, T6, T8, T24) after FLMA removal (T0).;Timepoint(s) of evaluation of this end point: 2, 4, 6, 8 and 24 hours (T2, T4, T6, T8, T24) after FLMA removal (T0).	—

Measure

Time frame

Secondary end point(s): • The effect and difference between Betamethasone gel (Diprol 0.05%), NSAID gel (Ipren gel 0.5%) and placebo (Neutral gel) lubricated FLMA on the sore throat at 2, 4, 8 and 24 hours (T2, T4, T8, T24) after FLMA removal (T0). • The effect and difference between Betamethasone gel (Diprol 0.05%), NSAID gel (Ipren gel 0.5%) and placebo (Neutral gel) lubricated FLMA on hoarseness and cough at 2, 4, 6, 8 and 24 hours ( T2, T4, T6, T8, T24) after FLMA removal (T0). • The consumption of analgesics at 2, 4, 6, 8 and 24 hours (T2, T4, T6, T8, T24) after FLMA removal (T0). • The occurrence of postoperative itching, numbness and burning sensation from the neck at 2, 4, 6, 8 and 24 hours (T2, T4, T6, T8, T24) after FLMA removal (T0).;Timepoint(s) of evaluation of this end point: 2, 4, 6, 8 and 24 hours (T2, T4, T6, T8, T24) after FLMA removal (T0).

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Countries

Denmark

Contacts

Public ContactNeuroanæstesiologisk Klinik, RH/Glo

Neuroanæstesiologisk Klinik, RH/Glostrup

mark.puch.oernskov@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026