Acute mountain sickness is a common ailment in people venturing over 2500 m altitude. Pilgrims to high altitudes are at an added risk since they are unaware and they gain height faster than the recommendations. Acetazolamide is the standard treatment and prophylaxis of acute mountain sickness. There are no randomized controlled trials that have studied protective effects of Acetazolamide in rapid ascent, and there are few conflicting studies regarding this matter. This study is a randomized, double blinded, placebo controlled trial of Acetazolamide versus placebo in 380 healthy individuals travelling to Gosaikunda Lake of Nepal in rates of ascent that are faster than the recommendations. Acetazolamide 125 mg twice daily and a placebo will be randomly assigned for 3 days and participants will be assessed at 3 stations. This study will undertake to establish the role of Acetazolamide in Rapid Ascent and will be the first RCT done in this issue. The investigators hypothesize that Acetazolamide 125mg twice daily given before rapid ascent to high altitude in Nepalese pilgrims will not be superior to placebo in decreasing both the incidence and severity of acute mountain sickness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
380
125 mg twice daily until 4380 meters altitude
Twice daily
Oxford University Clinical Research Unit Nepal
Kathmandu, Nepal
Diagnosis of acute mountain sickness
A diagnosis of AMS requires a score of three or greater on the Lake Louise Acute Mountain Sickness Questionnaire with the mandatory presence of headache and at least one of the following symptoms: dizziness or light-headedness, fatigue, gastrointestinal (GI) symptoms (nausea/vomiting), or difficulty sleeping.
Time frame: Upon reaching an altitude of 3300m, average expected time is 1 day
Diagnosis of acute mountain sickness
A diagnosis of AMS requires a score of three or greater on the Lake Louise Acute Mountain Sickness Questionnaire with the mandatory presence of headache and at least one of the following symptoms: dizziness or light-headedness, fatigue, gastrointestinal (GI) symptoms (nausea/vomiting), or difficulty sleeping.
Time frame: Upon reaching an altitude of 4380m, average expected time is 3 days
Blood oxygen saturation
Percent
Time frame: Upon reaching an altitude of 3300m, average expected time is 1 day
Heart rate
Beats per minute
Time frame: Upon reaching an altitude of 3300m, average expected time is 1 day
High altitude headache
High altitude headache severity will be scored in milimeters based on patient markings on a visual analog scale. The headache score will be identified on the designated Lake Louise Questionnaire.
Time frame: Upon reaching an altitude of 3300m, average expected time is 1 day
Blood oxygen saturation
Percent
Time frame: Upon reaching an altitude of 4380m, average expected time is 3 days
Heart rate
Beats per minute
Time frame: Upon reaching an altitude of 4380m, average expected time is 3 days
High altitude headache
High altitude headache severity will be scored in millimeters based on patient markings on a visual analog scale. The headache score will be identified on the designated Lake Louise Questionnaire.
Time frame: Upon reaching an altitude of 4380m, average expected time is 3 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.